ReagentsInfectious diseases

Controls/standards/calibrators - (infect. immunology/NAT)

EMDN code W010508

68 manufacturers, 835 models including 831 on the market, 20 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Manufacturer	Country	Registered models	Class	Contact
LGC Clinical Diagnostics EU representative : MediMark Europe Sarl. (France)	United States	A1 Series 2400 2000-000198/79 A1 Series 2500 2000-000298/79 A1 Series 2700 2000-000598/79 A1 Series 4000 2000-000898/79 A1 Series 4400 2000-001098/79 122 others A106 HIV-1 Ag 2015-006598/79 A106 HIV-1 Ag 2015-006698/79 A113 Anti-HBc IgM 2015-006898/79 A115 Anti-HBc IgG 2015-007098/79 A127 Anti-Delta 2015-007998/79 A21 Series 2000 CE 2000-003198/79 A325 Series 200 HBV DNA 2020-009698/79 A325 Series 700 HBV DNA 2020-009898/79 A51 Hepatitis Multi-Marker 2000-004098/79 A51 Hepatitis Multi-Marker 2000-004198/79 A52 Hepatitis Multi-Marker 2000-004398/79 Accurun 1 S8100 Positive Control 2000-002298/79 Accurun 1 Series 5100 positive control 2000-001698/79 Accurun 1 Series 5100 Positive Control 2000-001798/79 ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control 2015-007298/79 ACCURUN 120 Anti-HAV IgG 2015-007398/79 ACCURUN 121 HAV IgM Positive Control 2015-007498/79 ACCURUN 121 HAV IgM Positive Control 2015-007698/79 ACCURUN 125 Anti-HBs Positive Control 2015-007798/79 ACCURUN 125 Anti-HBs Positive Control 2015-007898/79 ACCURUN 130 Borrelia burgdorferi IgG Positive Control 2015-008098/79 ACCURUN 132 Borrelia burgdorferi IgM Positive Control 2015-008198/79 ACCURUN 135 Toxoplasma IgG Positive Control 2015-008298/79 ACCURUN 136 Toxoplasma IgM Positive Control 2015-008398/79 ACCURUN 140 Rubella IgG Positive Control 2015-008498/79 ACCURUN 141 Rubella IgM Positive Control 2015-008698/79 ACCURUN 145 CMV IgG Positive Control 2015-008798/79 ACCURUN 146 CMV IgM Positive Control 2015-008898/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000 2015-009098/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 2015-009298/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 2015-009398/79 ACCURUN 156 Reagin (Syphilis) Positive Control 2015-009498/79 ACCURUN 190 Chagas Positive Control 2015-009798/79 Accurun 2 Series 2700 2000-002398/79 Accurun 2 Series 2700 2000-002498/79 ACCURUN 21 Multi-Marker control Series 1000 2000-0028 ACCURUN 25 ToRCH IgG Positive Control S2000 2000-007498/79 ACCURUN 25 ToRCH IgG Positive Control S5000 2000-003498/79 ACCURUN 26 ToRC IgM Positive Control Series 5000 2000-003598/79 ACCURUN 30 EBV IgG Positive Control 2000-003798/79 ACCURUN 305 Series 100 HCV RNA 2020-008098/79 ACCURUN 305 Series 150 HCV RNA Positive Control 2020-007898/79 ACCURUN 305 Series 300 HCV RNA 2020-008398/79 ACCURUN 305 Series 400 HCV RNA 2020-008598/79 ACCURUN 31 EBV IgM Positive Control 2000-003898/79 ACCURUN 315 HIV-1 RNA Positive Quality Control Series 500 2020-009398/79 ACCURUN 315 Series 150 HIV-1 RNA 2020-008798/79 ACCURUN 315 Series 200 HIV-1 RNA 2020-009098/79 ACCURUN 315 Series 400 HIV-1 RNA 2020-009298/79 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 2025-006798/79 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 2025-006898/79 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 2020-010498/79 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 2020-010598/79 ACCURUN 372 HPV DNA Positive Control Series 400 2025-003798/79 ACCURUN 372 HPV DNA Positive Control Series 600 2025-004198/79 ACCURUN 378 HPV DNA Positive Control Series 5000 2025-004398/79 ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control 2025-006098/79 ACCURUN 501 C. difficile Control 2050-000898/79 ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 2000-006298/79 ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 2000-006798/79 ACCURUN 841 CT/NG Negative Control 2025-006198/79 ACCURUN 872 HPV DNA Negative Control 2035-000998/79 ACCURUN 873 HPV DNA Negative Control 2035-000598/79 ACCURUN Anti-SARS-CoV-2 IgM Controls Kit 2015-023298/79 ACCURUN Anti-SARS-CoV-2 Series 1000 2015-022298/79 ACCURUN Anti-SARS-CoV-2 Series 2000 2015-022598/79 ACCURUN EBV Positive Control 2020-0210 ACCURUN117 Hepatitis B e Antigen Positive Control 2015-007198/79 ACCURUN® 2 Multi-Marker Positive Control Series 2900 2000-0080 ACCURUN® 350 CMV DNA Positive Control 2020-0162 ACCURUN® Babesia Positive Molecular Control Kit 2020-0155 ACCURUN® TV/MG Positive Molecular Control Kit 2020-0164 Multichem ID HAV IgM Positive Control Multichem ID Rubella IgM Positive Control 2015-024098/79 Multichem ID ToRC IgM Positive Control 2000-010298/79 Multichem ID ToRCH IgG Positive Control 2000-010198/79 Optitrol Blue SR11011 Optitrol Blue SR11013 Optitrol Blue SR11019 Optitrol Chagas-1, 1x pos, 1mL SR160252 refs Optitrol Chagas-2, 1x pos, 1mL SR160352 refs Optitrol HEPA-1, 1x pos, 1mL SR120252 refs Optitrol HEPA-2, 1x pos, 1mL SR120352 refs Optitrol HEPR-1 SR120472 refs Optitrol HEPR-2, 1x pos, 1mL SR120572 refs Optitrol HIV 2, 1x pos, 1mL SR111133 refs Optitrol HIV p24, 1x pos,1mL SR111013 refs Optitrol HSV 2 SR130372 refs Optitrol Lyme/TBE G SR170183 refs Optitrol Lyme/TBE M SR170283 refs Optitrol Malaria SR160172 refs Optitrol Measles M SR150453 refs Optitrol Mumps M, 1x pos, 1mL SR150653 refs Optitrol NAT CMV, 10x 1.2 mL NT020212 refs Optitrol NAT CT/NG, 10x 1.2 mL NT020112 refs Optitrol NAT HAV, 10x 1.2 mL NT050112 refs Optitrol NAT HBV Screening, 10x 1,2 mL NT010112 refs Optitrol NAT HBV Viral Load, 10x 1.2 mL NT010132 refs Optitrol NAT HCV Screening, 10x 1,2 mL NT010212 refs Optitrol NAT HCV Viral Load, 10x 1.2 mL NT010232 refs Optitrol NAT HEV, 10x 1.2 mL NT011212 refs Optitrol NAT HIV Screening, 10x 1,2 mL NT010312 refs Optitrol NAT HIV Viral Load, 5x 1.2 mL NT01033 Optitrol NAT HIV-2, 10x 1,2 mL NT010352 refs Optitrol NAT HPV neg, 10x 1.2 mL NT060132 refs Optitrol NAT HPV, 10x 1.2 mL NT060112 refs Optitrol NAT NEG, 10x 1,2 mL NT010512 refs Optitrol NAT Parvo B19, 10x 1,2 mL NT050212 refs Optitrol NAT Triplex, 10x 1,2 mL NT010412 refs Optitrol Orange, 1x pos, 1mL SR110613 refs Optitrol Paediatric G negative, 2x neg, 2,5mL SR150253 refs Optitrol Paediatric G Pos SR150152 refs Optitrol Paediatric M Neg SR150032 refs Optitrol Parvo M SR150573 refs Optitrol Red, 1x pos, 1mL SR110513 refs Optitrol SeroNeg, 2x neg, 1mL SR110003 refs Optitrol Syphilis G SR111372 refs Optitrol ToRCH G Neg SR130193 refs Optitrol ToRCH M Neg SR130293 refs Optitrol VZV M SR150783 refs Optitrol Yellow 4x5 mL SR110213 refs VALIDATE® Anti-SARS-CoV2 IgG Test Set 510mm98/79	B IVDR, 98/79	EUDAMED record Report an error
Microbiologics EU representative : MediMark Europe Sarl. (France)	United States	8180 8181 8184 8187 8189 64 others 8190 8191 8203 8205 8206 8208 8209 8210 8211 8219 8227 8228 8229 8230 8231 8232 8234 8235 8236 8238 8242 8246 8247 8248 8249 8250 8254 8257 8258 8267 HE0013S HE0026N HE0027N HE0028N HE0029N HE0030N HE0031N HE0032N HE0033N HE0034N HE0035N HE0036N HE0037N HE0040N HE0041N HE0042N HE0043N HE0044N HE0045N HE0052N HE0053NS HE0054NS HE0055NS HE0056N HE0060S HE0061S HE0082HF Helix Elite Molecular Standards HE0012S Helix Elite™ Molecular Standards: Inactivated Standard HE0038N Helix Elite™ Molecular Standards: Inactivated Standard HE0039N Helix Elite™ Molecular Standards: Inactivated Standard HE0057N KWIK-STIK™ and LYFO DISK™ 0151 KWIK-STIK™ and LYFO DISK™ 0156 KWIK-STIK™ and LYFO DISK™ 0262	A, B IVDR	Website info@microbiologics.com EUDAMED record Report an error
DiaSorin EU representative : DiaSorin Italia S.p.A. (Italy)	Italy, United States	LIAISON® Adenovirus Control Set98/79 LIAISON® Biotrin Control Parvovirus B19 IgG98/79 LIAISON® Biotrin Control Parvovirus B19 IgG Plus LIAISON® Biotrin Control Parvovirus B19 IgM98/79 LIAISON® Biotrin Control Parvovirus B19 IgM Plus 56 others LIAISON® C. difficile GDH Control Set98/79 LIAISON® C. difficile Toxins A&B Control Set98/79 LIAISON® Control Anti-HAV LIAISON® Control Bordetella pertussis Toxin IgA LIAISON® Control Bordetella pertussis Toxin IgG LIAISON® Control Borrelia IgG LIAISON® Control Borrelia IgG Liquor LIAISON® Control Borrelia IgM Liquor LIAISON® Control Borrelia IgM Quant / Borrelia IgM II LIAISON® Control Chlamydia trachomatis IgA LIAISON® Control Chlamydia trachomatis IgG LIAISON® Control CMV IgG Avidity II LIAISON® Control CMV IgG II98/79 LIAISON® Control EA IgG LIAISON® Control EBNA IgG LIAISON® Control EBV IgM LIAISON® Control HSV-1 IgG98/79 LIAISON® Control HSV-1/2 IgG LIAISON® Control HSV-1/2 IgM98/79 LIAISON® Control HSV-2 IgG LIAISON® Control Legionella Urinary Ag LIAISON® Control LymeDetect® LIAISON® Control Measles IgM LIAISON® Control Mumps IgG98/79 LIAISON® Control Mumps IgM LIAISON® Control Mycoplasma pneumoniae IgG98/79 LIAISON® Control Mycoplasma pneumoniae IgM LIAISON® Control QuantiFERON®-TB Gold Plus2 refs LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® Control Rubella IgG98/79 LIAISON® Control Rubella IgG II LIAISON® Control Rubella IgM LIAISON® Control S. pneumoniae Ag LIAISON® Control SARS-CoV-2 Ag LIAISON® Control Toxo IgG II LIAISON® Control Toxo IgM LIAISON® Control VCA IgG LIAISON® Control VZV IgG98/79 LIAISON® Control VZV IgG HT LIAISON® Control VZV IgM LIAISON® H. pylori IgG Control Set98/79 LIAISON® Meridian H. pylori SA Control Set98/79 LIAISON® MUREX Control Anti-HEV IgG LIAISON® MUREX Control Anti-HEV IgM LIAISON® Rotavirus Control Set98/79 LIAISON® SARS-CoV-2 TrimericS IgG Control Set98/79 LIAISON® XL Control Toxo IgG Avidity LIAISON®Control HAV lgM98/79 Simplexa™ Bordetella Positive Control Pack98/79 Simplexa™ C. auris Positive Control Pack Simplexa™ COVID-19 & Flu A/B Positive Control Pack98/79 Simplexa™ COVID-19 / Flu A/B & RSV Positive Control Pack Simplexa™ COVID-19 Positive Control Pack98/79 Simplexa™ Flu A/B & RSV Positive Control Pack98/79 Simplexa™ Group A Strep Positive Control Pack98/79 Simplexa™ HSV 1 & 2 Positive Control Pack98/79	B, C IVDR, 98/79	Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Mikrogen	Germany	B. pertussis IgA Positivkontrollserum98/79 B. pertussis IgG Positivkontrollserum98/79 B. pertussis IgG/IgA Negativkontrollserum98/79 Borrelia IgG Positivkontrollserum98/79 Borrelia IgG/IgM Negativkontrollserum98/79 46 others Borrelia IgM Positivkontrollserum98/79 Campylobacter IgA Positivkontrollserum98/79 Campylobacter IgG Positivkontrollserum98/79 Campylobacter IgG/IgA Negativkontrollserum98/79 Chlamydia IgA Positivkontrollserum (C. pneumoniae, C. trachomatis)98/79 Chlamydia IgG Positivkontrollserum (C. pneumoniae, C. trachomatis)98/79 Chlamydia IgG/IgA Negativkontrollserum98/79 CMV IgG Positivkontrollserum98/79 CMV IgG/IgM Negativkontrollserum98/79 CMV IgM Positivkontrollserum98/79 EBV IgA Positivkontrollserum98/79 EBV IgG Positivkontrollserum98/79 EBV IgG/IgM/IgA Negativkontrollserum98/79 EBV IgM Positivkontrollserum98/79 Hantavirus IgG Positivkontrollserum98/79 Hantavirus IgG/IgM Negativkontrollserum98/79 Hantavirus IgM Positivkontrollserum98/79 Helicobacter IgA Positivkontrollserum98/79 Helicobacter IgG Positivkontrollserum98/79 Helicobacter IgG/IgA Negativkontrollserum98/79 HEV IgG Positivkontrollserum98/79 HEV IgG/IgM Negativkontrollserum98/79 HEV IgM Positivkontrollserum98/79 HSV IgG Negativkontrollserum98/79 HSV IgG Positivkontrollserum98/79 Parvovirus IgG Positivkontrollserum98/79 Parvovirus IgG/IgM Negativkontrollserum98/79 Parvovirus IgM Positivkontrollserum98/79 recomCLIA Control Set Borrelia IgG recomCLIA Control Set Borrelia IgM recomCLIA Control Set HEV IgG recomCLIA Control Set HEV IgM Rubella IgG Negativkontrollserum98/79 Rubella IgG Positivkontrollserum98/79 SARS-CoV-2 IgG Negativkontrollserum98/79 SARS-CoV-2 IgG Positivkontrollserum98/79 Toxoplasma IgG Positivkontrollserum98/79 Toxoplasma IgG/IgM Negativkontrollserum98/79 Toxoplasma IgM Positivkontrollserum98/79 Treponema IgG Positivkontrollserum98/79 Treponema IgG/IgM Negativkontrollserum98/79 Treponema IgM Positivkontrollserum98/79 Yersinia IgA Positivkontrollserum98/79 Yersinia IgG Positivkontrollserum98/79 Yersinia IgG/IgM/IgA Negativkontrollserum98/79 Yersinia IgM Positivkontrollserum98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Euroimmun	Germany	Control set Anti-Borrelia ChLIA (IgG) LR 2132 G98/79 Control set Anti-Borrelia ChLIA (IgM) LR 2132 M98/79 Control set Anti-EBNA-1 ChLIA (IgG) LR 2793 G98/79 Control set Anti-EBV-CA ChLIA (IgG) LR 2791 G98/79 Control set Anti-EBV-CA ChLIA (IgM) LR 2791 M98/79 41 others Control set Anti-HSV 1 ChLIA (IgG) LR 2531 G98/79 Control set Anti-HSV 2 ChLIA (IgG) LR 2532 G98/79 Control set Anti-SARS-CoV-2 RBD ChLIA (IgG) LR 2606-1 G98/79 CSQ pair of controls Anti-Borrelia (IgG) CK 2132-L G98/79 CSQ pair of controls Anti-CMV (IgG) CK 2570-L G98/79 CSQ pair of controls Anti-EBV-CA (IgG) CK 2791-L G98/79 CSQ pair of controls Anti-HSV-1/2 Pool (IgG) CK 2531-1 L G98/79 CSQ pair of controls Anti-Measles virus (IgG) CK 2610-L G98/79 CSQ pair of controls Anti-Mumps virus (IgG) CK 2630-L G98/79 CSQ pair of controls Anti-Rubella virus (IgG) CK 2590-L G98/79 CSQ pair of controls Anti-Toxoplasma gondii (IgG) CK 2410-L G98/79 CSQ pair of controls Anti-Treponema pallidum (IgG) CK 2111-L G98/79 CSQ pair of controls Anti-VZV (IgG) CK 2650-L G98/79 Pos. control: anti-Borrelia afzelii (IgG), 50x concentrate CW 2131 G98/79 Pos. control: anti-Borrelia afzelii (IgM), 50x concentrate CW 2131 M98/79 Pos. control: anti-Borrelia burgdorferi (IgG), 50x concentrate CW 2132 G98/79 Pos. control: anti-Borrelia burgdorferi (IgM), 50x concentrate CW 2132 M98/79 Pos. control: anti-Borrelia garinii (IgG), 50x concentrate CW 2134 G98/79 Pos. control: anti-Borrelia garinii (IgM), 50x concentrate CW 2134 M98/79 Pos. control: anti-Echinococcus (IgG), 50x concentrate CW 2321 G98/79 Pos. control: anti-Helicobacter pylori (IgA), 50x concentrated CW 2080 A98/79 Pos. control: anti-Helicobacter pylori (IgG), 50x concentrated CW 2080 G98/79 Pos. control: anti-Herpes-simplex-virus (HSV) (IgG), 50x concentrate CW 2531 G98/79 Pos. control: anti-Yersinia enterocolitica (IgA), 50x concentrate CW 2173 A98/79 Pos. control: anti-Yersinia enterocolitica (IgG), 50x concentrate CW 2173 G98/79 Positive control (IgA, human), 50x concentrated CL 2050 A98/79 Positive control (IgA, human), 50x concentrated CL 2173 A98/79 Positive control (IgA, human), 50x concentrated CL 2525 A98/79 Positive control (IgG, human), 50x concentrated CL 2050 G98/79 Positive control (IgG, human), 50x concentrated CL 2111 G98/79 Positive control (IgG, human), 50x concentrated CL 2131 G98/79 Positive control (IgG, human), 50x concentrated CL 2173 G98/79 Positive control (IgG, human), 50x concentrated CL 2525 G98/79 Positive control (IgG, human), 50x concentrated CL 2570 G98/79 Positive control (IgG, human), 50x concentrated CL 2790-12 G98/79 Positive control (IgM, human), 50x concentrated CL 2111 M98/79 Positive control (IgM, human), 50x concentrated CL 2131 M98/79 Positive control (IgM, human), 50x concentrated CL 2570 M98/79 Positive control (IgM, human), 50x concentrated CL 2790-12 M98/79 Positive control: anti-Treponema pallidum (IgG), 50x concentrate CW 2111 G98/79 Positive control: anti-Treponema pallidum (IgM), 50x concentrate CW 2111 M98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Orientgene EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Adenovirus Antigen Control Kit GCADE-PN298/79 Adenovirus Antigen FIA Control Kit FCADE-PN298/79 AMTBZK01-AHG2E98/79 CAMRZK01-AOG4E98/79 CCDIFZK01-AOG4E98/79 24 others CCNSZK01-AOG4E98/79 CDGVZK01-AOG4E98/79 CGBSZK01A-AOG4E98/79 CGIBACZK01-AOG4E98/79 CGIZK01-AOG4E98/79 CHPV14ZK01-AOG4E98/79 CMTBMDRZK01-AOG4E98/79 CMTBNTMZK01-AHG4E98/79 CMTBRIFZK01-AOG4E98/79 COVID-19/Flu A&B/RSV/Adeno Ag Control Kit GCFCRA-PN298/79 CRTI7BZK01-AOG4E98/79 CRTI7CZK01-AOG4E98/79 CRTIZK01-AOG4E98/79 CSTI6ZK01A-AOG4E98/79 CSTIAZK01-AOG4E98/79 CSTIBZK01-AOG4E98/79 CSTIZK01A-AOG4E98/79 CVAGZK01-AOG4E98/79 CVCBZK01-AOG4E98/79 H. pylori Ag Control Kit GCHP-PN298/79 Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN298/79 RSV Antigen Control Kit GCRSV-PN2，GCRSV-PN1098/79 RSV Antigen FIA Control Kit FCRSV-PN298/79 Strep A Antigen Control Kit GCSTR-PN298/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	AMPLIRUN® ADENOVIRUS DNA CONTROL MBC001 AMPLIRUN® CHLAMYDIA TRACHOMATIS DNA CONTROL MBC012 AMPLIRUN® CHLAMYDOPHILA PNEUMONIAE DNA CONTROL MBC011 AMPLIRUN® CYTOMEGALOVIRUS DNA CONTROL MBC016 AMPLIRUN® ENTEROVIRUS 68 RNA CONTROL MBC125 24 others AMPLIRUN® ENTEROVIRUS 71 RNA CONTROL MBC019 AMPLIRUN® EPSTEIN-BARR VIRUS DNA CONTROL MBC065 AMPLIRUN® HERPES SIMPLEX 1 DNA CONTROL MBC023 AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL MBC024 AMPLIRUN® INFLUENZA A H1 RNA CONTROL MBC028 AMPLIRUN® INFLUENZA A H3 RNA CONTROL MBC029 AMPLIRUN® INFLUENZA A H5 RNA CONTROL MBC052 AMPLIRUN® INFLUENZA B RNA CONTROL MBC030 AMPLIRUN® MYCOBACTERIUM TUBERCULOSIS DNA CONTROL MBC034 AMPLIRUN® NEISSERIA GONORRHOEAE DNA CONTROL MBC075 AMPLIRUN® NOVEL INFLUENZA A H1N1 RNA CONTROL MBC082 AMPLIRUN® PARAINFLUENZA 1 RNA CONTROL MBC037 AMPLIRUN® PARAINFLUENZA 2 RNA CONTROL MBC038 AMPLIRUN® PARAINFLUENZA 3 RNA CONTROL MBC039 AMPLIRUN® PARAINFLUENZA 4 A RNA CONTROL MBC050 AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (A) RNA CONTROL MBC041 AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (B) RNA CONTROL MBC083 AMPLIRUN® RHINOVIRUS RNA CONTROL MBC091 AMPLIRUN® SARS-CoV-2 RNA CONTROL MBC13798/79 AMPLIRUN® TOXOPLASMA GONDII DNA CONTROL MBC047 AMPLIRUN® TREPONEMA PALLIDUM DNA CONTROL MBC109 AMPLIRUN® TRICHOMONAS VAGINALIS DNA CONTROL MBC079 AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL MBC048 VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL VEC001	B, C IVDR, 98/79	EUDAMED record Report an error
Biologicals Quality Control	Netherlands	P0048 ViraQ Negative3 refs P0063 ViraQ HCV Check 1252 refs P0064 ViraQ HIV-1 Check 1252 refs P0065 ViraQ HBV Check 1252 refs P0067 ViraQ HCV Trend 252 refs 22 others P0068 ViraQ HIV-1 Trend 25 P0077 SeraQ TPHA Syphilis2 refs P0078 SeraQ ARCHITECT2 refs P0154 ViraQ HBV Trend 502 refs P0179 SeraQ Elecsys2 refs P0180 SeraQ LIAISON2 refs P0237 SeraQ LIAISON Syphilis2 refs P0247 ViraQ WNV Check 1253 refs P0259 SeraQ Murex2 refs P0260 SeraQ Murex Syphilis2 refs P0264 ViraQ HEV Check 1253 refs P0266 ViraQ Parvo B19/HAV Check3 refs P0267 SeraQ TPHA Syphilis V22 refs P0273 ViraQ Multi-Marker Check 752 refs P0309 SeraQ BIO-RAD2 refs P0312 SeraQ Elecsys Syphilis2 refs P0313 SeraQ BIO-RAD Syphilis2 refs P0317 SeraQ Alinity Syphilis2 refs P0318 ViraQ HIV-2 Check 1253 refs P0320 SeraQ Alinity V22 refs P0374 SeraQ Alinity V32 refs P0386 SeraQ Alinity V42 refs	B IVDR	Website info@bioqcontrol.com EUDAMED record Report an error
Qnostics EU representative : WMDE B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Qnostics Ltd Adenovirus (ADV) Analytical Q Panel98/79 Qnostics Ltd Adenovirus (ADV) Molecular Q Control98/79 Qnostics Ltd Adenovirus (ADV) Molecular Q Panel98/79 Qnostics Ltd BK Virus (BKV) Analytical Q Panel98/79 Qnostics Ltd BK Virus (BKV) Molecular Q Control98/79 21 others Qnostics Ltd BK Virus (BKV) Molecular Q Panel98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Analytical Q Panel98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Molecular Q Control98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Molecular Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Analytical Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Molecular Q Control98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Molecular Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Analytical Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Molecular Q Control98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Molecular Q Panel98/79 Qnostics Ltd Influenza B virus (INFB) Molecular Q Control98/79 Qnostics Ltd JC Virus (JCV) Molecular Q Control98/79 Qnostics Ltd Respiratory Syncytial Virus A (RSVA) Molecular Q Control98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Analytical Q Panel98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Molecular Q Control98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Molecular Q Panel98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Analytical Q Panel98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Molecular Q Control98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Molecular Q Panel98/79 Qnostics Ltd. Influenza A virus (INFA) Molecular Q Control98/79 Qnostics Ltd. JC Virus (JCV) Molecular Q Panel98/79	– 98/79	quality@qnostics.com EUDAMED record Report an error
Microgenics EU representative : B·R·A·H·M·S GmbH (Germany)	United States	96005098/79 96005198/79 96049998/79 96050098/79 96050198/79 20 others 96060098/79 96123098/79 96123198/79 96124098/79 96124198/79 96124298/79 96300198/79 96300298/79 96300398/79 96400198/79 96400298/79 96400398/79 96460098/79 96500198/79 96500298/79 96500398/79 96714698/79 96715098/79 96715198/79 96903298/79	– 98/79	Website EUDAMED record Report an error
Healgen EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Adenovirus Antigen Control Kit GCADE-PN298/79 Adenovirus Antigen FIA Control Kit FCADE-PN298/79 AMTBZK01-AHG2E98/79 CAMRZK01-AHG4E98/79 CCDIFZK01-AHG4E98/79 17 others CCNSZK01-AHG4E98/79 CGIBACZK01-AHG4E98/79 CGIZK01-AHG4E98/79 CHPV14ZK01-AHG4E98/79 CMTBNTMZK01A-AHG4E98/79 CRTI7BZK01-AHG4E98/79 CRTI7CZK01-AHG4E98/79 CSTI6ZK01A-AHG4E98/79 CSTIAZK01-AHG4E98/79 CSTIBZK01-AHG4E98/79 CVAGZK01-AHG4E98/79 CVCBZK01-AHG4E98/79 Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN298/79 RSV Antigen Control Kit GCRSV-PN1098/79 RSV Antigen Control Kit GCRSV-PN298/79 RSV Antigen FIA Control Kit FCRSV-PN298/79 Strep A Antigen Control Kit GCSTR-PN298/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Shenzhen Yhlo Biotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Anti-TP Control98/79 Chlamydia pn. IgG Control Chlamydia pn. IgM Control CMV IgG Control CC843 CMV IgM Control CC844 17 others EB EA IgM Control98/79 EB NA IgA Control98/79 EB NA IgG Control98/79 EB VCA IgA Control98/79 EB VCA IgG Control98/79 EB VCA IgM Control98/79 HSV-1 IgG Control98/79 HSV-1 IgM Control98/79 HSV-2 IgG Control98/79 HSV-2 IgM Control98/79 M. Pneumoniae IgG Control CC84798/79 M. Pneumoniae IgM Control CC84898/79 Procalcitonin Control CC82098/79 Rubella IgG Control CC845 Rubella IgM Control CC846 Toxo IgG Control Toxo IgM Control	C IVDR, 98/79	Website info@szyhlo.com EUDAMED record Report an error
DiaMex	Germany	Optitrol Blue3 refs Optitrol Green3 refs Optitrol HEPA-13 refs Optitrol HEPR-13 refs Optitrol HIV 23 refs 15 others Optitrol HIVp243 refs Optitrol NAT HBV Screening No2 refs Optitrol NAT HBV Viral Load2 refs Optitrol NAT HCV Screening Optitrol NAT HCV Viral Load2 refs Optitrol NAT HEV2 refs Optitrol NAT HIV Screening2 refs Optitrol NAT HIV Viral Load2 refs Optitrol NAT HIV-22 refs Optitrol NAT NEG2 refs Optitrol NAT Triplex2 refs Optitrol Orange3 refs Optitrol Red3 refs Optitrol SeroNeg3 refs Optitrol Yellow3 refs	B IVDR	Website EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls MAGLUMI Anti-HAV (CLIA) Controls MAGLUMI Chlamydia pneumoniae IgG (CLIA) Controls MAGLUMI Chlamydia pneumoniae IgM (CLIA) Controls 15 others MAGLUMI CMV IgG (CLIA) Controls MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls MAGLUMI EBV EA IgA (CLIA) Controls MAGLUMI EBV EA IgG (CLIA) Controls MAGLUMI EBV NA IgA (CLIA) Controls MAGLUMI EBV VCA IgA (CLIA) Controls MAGLUMI H.pylori IgM (CLIA) Controls MAGLUMI HEV IgG (CLIA) Controls MAGLUMI HEV IgM (CLIA) Controls MAGLUMI HSV-1 IgM (CLIA) Controls MAGLUMI HSV-1/2 IgM (CLIA) Controls MAGLUMI HSV-2 IgM (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgG (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgM (CLIA) Controls MAGLUMI Toxo IgG (CLIA) Controls	B, C IVDR	Website EUDAMED record Report an error
Abbott EU representative : Emergo Europe B.V. (Netherlands) and 1 other	Ireland, South Korea, United States	Alinity 06S610198/79 Alinity 06S611098/79 Alinity SARS-CoV-2 IgG2 refs98/79 Alinity SARS-CoV-2 IgM98/79 ARCHITECT 06S600198/79 12 others ARCHITECT 06S601098/79 ARCHITECT SARS-CoV-2 IgG (Cal & Ctrl)2 refs98/79 ARCHITECT SARS-CoV-2 IgM2 refs98/79 BinaxNOW™ Influenza A & B Card Control Swab Kit 416-08098/79 BinaxNOW™ Strep A Card (25T) 735-02598/79 Bioline™ Malaria Control Kit 05FK10C98/79 ID NOW™ COVID-19 2.0 Control Swab Kit (12 POS+12 NEG) 192-08098/79 ID NOW™ Influenza A & B 2 Control Swab Kit (12 POS+12 NEG) 425-08098/79 ID NOW™ RSV (24T) 435-00098/79 ID NOW™ RSV Control Swab Kit (12 POS+12 NEG) 435-08098/79 ID NOW™ Strep A 2 Control Swab Kit (12 POS+12 NEG) 734-08098/79 SD BIOLINE Malaria Control Kit 05FK10C98/79	– 98/79	Website EUDAMED record Report an error
Siemens Healthcare Diagnostics EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC2 refs ADVIA Centaur HAV IgM (aHAVM) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC2 refs ADVIA Centaur HAV Total (aHAVT) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC2 refs ADVIA Centaur HBc IgM (aHBcM) Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHBcM QC2 refs ADVIA Centaur HBeAg (HBe) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC2 refs 11 others ADVIA Centaur HBsAg Quality Control Material IVDR_67_TTN_DUB-C_D_REAG_HBsAg Quality Control2 refs ADVIA Centaur HCV Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHCV QC2 refs ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC2 refs ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC2 refs ADVIA Centaur HIV Ag/Ab Combo Quality Control (CHIV QC) IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC2 refs ADVIA Centaur Rub G quality control material IVDR_67_TTN_DUB-C_C_REAG_Rub G QC2 refs ADVIA Centaur Rub M quality control material IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material2 refs ADVIA Centaur Syphilis Quality Control Material DX LS_LEGACY_0063041458061698/79 ADVIA Centaur Toxo G Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_ToxoG_QC2 refs ADVIA Centaur Toxo M Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC2 refs Atellica IM Syphilis Quality Control (Syph QC) DX LS_LEGACY_0063041459989298/79	B, C, D IVDR, 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other	Australia	RIDA®Plex Positive Control Bacteria and Resistances98/79 RIDA®Plex Positive Control CSF98/79 RIDA®Plex Positive Control Faecal Pathogens98/79 RIDA®Plex Positive Control Fungal Panels98/79 RIDA®Plex Positive Control Pneumonia98/79 10 others RIDA®Plex Positive Control Respiratory Pathogens98/79 RIDA®Plex Positive Control STIs and Herpes98/79 Synthetic Positive Controls for Atypical Pneumonia98/79 Synthetic Positive Controls for Bacteria and Bacterial Resistance98/79 Synthetic Positive Controls for CSF98/79 Synthetic Positive Controls for Faecal Panels98/79 Synthetic Positive Controls for Fungal Panels98/79 Synthetic Positive Controls for HPV98/79 Synthetic Positive Controls for Respiratory Pathogens98/79 Synthetic Positive Controls for STIs and Herpes98/79	– 98/79	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Technogenetics	Italy	IDS Borrelia Control Set IDS CMV Avidity Control Set IDS CMV Control Set IDS EBV Control Set IDS HSV 1/2 IgG Control Set 8 others IDS HSV 1/2 IgM Control Set IDS MMV IgG Control Set IDS MMV IgM Control Set IDS Parvovirus B19 Control Set IDS Rubella Avidity Control Set IDS Rubella Control Set IDS Tetanus IgG Control Set IDS TOXO Control Set	B, C IVDR	Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-ADENO STANDARD2 refs98/79 REALQUALITY RQ-CMV STANDARD2 refs98/79 REALQUALITY RQ-EBV STANDARD2 refs98/79 REALQUALITY RQ-ENTERO STANDARD2 refs98/79 REALQUALITY RQ-HHV 6 STANDARD2 refs98/79 6 others REALQUALITY RQ-HHV 7 STANDARD2 refs98/79 REALQUALITY RQ-HHV 8 STANDARD2 refs98/79 REALQUALITY RQ-HSV 1 STANDARD2 refs98/79 REALQUALITY RQ-HSV 2 STANDARD2 refs98/79 REALQUALITY RQ-JCV STANDARD2 refs98/79 REALQUALITY RQ-PARVO B19 STANDARD2 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Boditech EU representative : Obelis s.a. (Belgium)	South Korea	Boditech CHIKV IgG/IgM Control98/79 Boditech COVID-19 Ag Control98/79 Boditech COVID-19 Ag Control Swab98/79 Boditech Dengue IgG/IgM Control98/79 Boditech Dengue NS1 Ag Control98/79 6 others Boditech H. pylori Ag Calibrator98/79 Boditech H. pylori Ag Control98/79 Boditech IGRA-TB Control Boditech NORO Control98/79 Boditech ROTA Control98/79 Boditech Rota/Adeno Control98/79	C IVDR, 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Denizbiyokimya	Türkiye	INNOVIQURE HAV Ab - Reagent CALIBRATORS98/79 INNOVIQURE HAV IgM - Reagent CALIBRATORS98/79 INNOVIQURE HBc Ab - Reagent CALIBRATORS98/79 INNOVIQURE HBc IgM - Reagent CALIBRATORS98/79 INNOVIQURE HBe Ab - Reagent CALIBRATORS98/79 6 others INNOVIQURE HBe Ag - Reagent CALIBRATORS98/79 INNOVIQURE HBs Ab - Reagent CALIBRATORS98/79 INNOVIQURE HCV Ab - Reagent CALIBRATORS98/79 INNOVIQURE HIV 1/2 Ab - Reagent CALIBRATORS98/79 INNOVIQURE HIV Combo Ag/Ab - Reagent CALIBRATORS98/79 INNOVIQURE HTLV I/II Ab - Reagent CALIBRATORS98/79	– 98/79	EUDAMED record Report an error
Beckman Coulter EU representative : Beckman Coulter Ireland Inc. (Ireland)	United States	Access anti-HAV Calibrator C39445 Access anti-HAV IgM Calibrator C39448 Access anti-HAV IgM QC C39449 Access anti-HAV QC C39446 Access CMV IgG Calibrators A4070398/79 4 others Access CMV IgM, Calibrators A4070698/79 Access HBc IgM (Reagent Pack)98/79 Access RUBELLA IgM CALIBRATORS98/79 Access Toxo IgG Calibrators98/79	B IVDR, 98/79	Website EUDAMED record Report an error
ElitechGroup	Italy	ASPERGILLUS spp. - ELITe Positive Control98/79 ASPERGILLUS spp. ELITe Standard98/79 C. difficile - ELITe Positive Control98/79 HEV - ELITe Positive Control98/79 HEV ELITe Standard98/79 4 others Meningitis Bacterial - ELITe Positive Control98/79 Respiratory Viral PLUS - ELITe Positive Control98/79 WNV - ELITe Positive Control98/79 WNV ELITe Standard98/79	– 98/79	Website EUDAMED record Report an error
Bio-Rad	France	Access HCV Ab V3 Calibrators B3345998/79 Access HCV Ab V3 QC B3346098/79 Access HIV combo V2 Calibrators C2843198/79 Access HIV combo V2 QC C2843298/79 Access HIV combo V2 QC plus C4357698/79 3 others Geenius HIV 1/2 Confirmatory Controls 7232998/79 Platelia Aspergillus IgG Negative & Positive controls Platelia Candida Ab Plus Negative & Positive controls	C IVDR, 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United Kingdom (ex Northern Ireland)	ADVIA Centaur HBc Total 2 (HBcT2) Quality Control IVDR_67_LLB_DUB-C_D_REAG_HBc Total 2 QC2 refs ADVIA Centaur Quantitative HBsAg (QHBs) Quality Control IVDR_67_LLB_DUB-C_C_REAG_QHBs QC2 refs IMMULITE CMV IgG Control IVDR_67_LLB_DUB-C_C_REAG_CMV IgG Controls IMMULITE H. pylori IgG Control Module IVDR_67_LLB_DUB-C_B_REAG_H. pylori IgG Control Module IMMULITE Rubella IgG Controls IVDR_67_LLB_DUB-C_C_REAG_Rubella IgG Controls 3 others IMMULITE Rubella IgM Control Module IVDR_67_LLB_DUB-C_C_REAG_Rubella IgM Controls IMMULITE Syphilis Control Module IVDR_67_LLB_DUB-C_C_REAG_Syphilis Control Module IMMULITE Toxoplasma IgG Control Module IVDR_67_LLB_DUB-C_C_REAG_Toxoplasma IgG Control Module	B, C, D IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Operon	Spain	CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL 9.230.XXX.12.ZZZ98/79 Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control 9.144.011.12.000 CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL 9.065.XXX.12.ZZZ CONTROL POSITIVO EN SECO H.PYL-TF \|\| H.PYL-TF DRY POSITIVE CONTROL 9.231.XXX.12.ZZZ CONTROL POSITIVO EN SECO ROTA-ADENO-NORO \|\| DRY POSITIVE CONTROL ROTA-ADENO-NORO 9.050.XXX.12.ZZZ 2 others CONTROL POSITIVO EN SECO SARS-CoV-2/Flu A+B / SARS-CoV-2/Flu A+B DRY POSITIVE CONTROL 9.242.XXX.12.ZZZ CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL 9.108.XXX.37.ZZZ98/79	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler ADVQ98/79 RealCycler AURQ98/79 RealCycler B19Q98/79 RealCycler BKVQ98/79 RealCycler BPAQ98/79 2 others RealCycler BPEQ98/79 RealCycler EBVQ98/79	– 98/79	EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Control For Adenovirus antigen ADV-CONTROL98/79 Control For Cryptococcus 048Z98/79 Control For Flu A/B antigen98/79 Control For Helicobacter Pylori (H.Pylori) H.Pylori Ag-CONTROL 099Z98/79 Control For Respiratory Syncytial Virus (RSV) antigen 057Z98/79 1 other Control For SARS-CoV-2 Antigen SARS-CoV-2-CONTROL98/79	– 98/79	Website EUDAMED record Report an error
Maine Molecular Quality Controls EU representative : QbD RepS BV (Belgium)	United States	BioFire JI Control Panel M42098/79 BioFire RP2.1/RP2.1plus Control Panel M441 M441-CE98/79 eplex RP2 Control M45198/79 FilmArray BCID2 Control Panel M41698/79 FilmArray GI Control Panel M238 M238-CE 1 other FilmArray® Pneumonia/Pneumoniaplus Control M34098/79	B IVDR, 98/79	Website info@mmqci.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Flu A&B External Control Set98/79 VitaPCR RSV External Control Set98/79 VitaPCR SARS-CoV-2 External Control Set98/79 VitaPCR SARS-CoV-2 Gen 2 External Control Set VitaPCR SARS-CoV-2 Gen2 External Control Set98/79 VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET HEV Positive Control98/79 PoET Internal Control98/79 PoET Master Positive Control98/79 PoET Negative Control98/79 PoET WNV Positive Control98/79	– 98/79	Website info@gfeblut.de EUDAMED record Report an error
Meridian Bioscience EU representative : Meridian Bioscience Europe S.r.l. (Italy)	United States	Alethia CMV External Controls alethia® Group B Streptococcus External Control Kit alethia® HSV 1&2 External Control Kit alethia® Malaria External Control Kit alethia® Pertussis External Control Kit	C IVDR	Website EUDAMED record Report an error
Microbix EU representative : Obelis s.a. (Belgium)	Canada	REDx HPV 16 Positive Control RED-62-163 refs REDx Mycoplasma genitalium Positive Control RED-63-01 REDx SARS-CoV-2 Negative Control RED-19-013 refs REDx STI Negative RED-99-M1 REDxFLOQ Respiratory Swab Negative Control RED-S-99-012 refs	B IVDR	Website customer.service@microbix.com EUDAMED record Report an error
NanoEntek EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	COVID-19 IgG/IgM Control LQ98/79 COVID-19 Neutralization Ab Control LQ98/79 COVID-19 SP Control LQ98/79 FIC-CGSW COVID-19 Ag positive control swab, Negative control swab98/79 Influenza A&B control swab FIC-FLSW98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
Oxoid EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE IMAGEN hMPV Positive Control Slide98/79 IMAGEN HSV POSITIVE CONTROL SLIDE PATHODXTRA POSITIVE CONTROL POLYVALENT POSITIVE CONTROL DR0592G	C IVDR, 98/79	Website EUDAMED record Report an error
Dialab	Austria	Polyvalent Negative Control98/79 Polyvalent Positive Control98/79 Syphilis RPR Negative Control98/79 Syphilis RPR Positive Control98/79	– 98/79	Website office@dialab.at EUDAMED record Report an error
Getein EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HSV-Ⅰ IgG Control (CLIA)98/79 HSV-Ⅰ IgM Control (CLIA)98/79 HSV-Ⅱ IgG Control (CLIA)98/79 HSV-Ⅱ IgM Control (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Gonorrhea Control98/79 Malaria P.f. /Pan Control SCMPN-D98/79 Malaria P.f./P.v. Control SCMPV-D98/79 Syphilis Control98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Hangzhou Danwei Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CDGVZK01-AHG4E98/79 CGBSZK01A-AHG4E98/79 CMTBMDRZK01-AHG4E98/79 CMTBRIFZK01-AHG4E98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Mindray EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HAV IgM and HEV IgM Multi Control 105-043944-00, 105-043943-00, 105-043942-00, 105-043941-003 refs ToRCH IgG Positive Control 105-024832-00、105-024833-00、105-024834-00、105-024835-003 refs ToRCH IgG/IgM Negative Control 105-024824-00、105-024825-00、105-024826-00、105-024827-003 refs ToRCH IgM Positive Control 105-024840-00、105-024841-00、105-024842-00、105-024843-003 refs	C IVDR	Website EUDAMED record Report an error
Etablissement Francais Du Sang	France	NatQal B19-L NatQal 23 refs NatQal HBV NatQal 13 refs SeroQal ALINI 63 refs SeroQal MALARIA 10198/79 (no longer marketed)	B IVDR, 98/79	EUDAMED record Report an error
Biosynex	France	Control Set for rapid SARS-CoV-2 PCR98/79 MALARIA Control98/79 Negative control swab98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Genekam	Germany	FR118-Human specific DNA-Internal Control (Realtime PCR-Kit) FR799-Identification of human specific ß-Actin K025-Identification of human specific DNA98/79	A IVDR, 98/79	Website office@genekam.de EUDAMED record Report an error
Geneproof	Czechia	GeneProof Universal Internal Control3 refs myCROBE Universal Control Set myCROBE Universal Internal Control98/79	B, C IVDR, 98/79	Website support@geneproof.com EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	AGS. FEB. SALMONELLA, CTRL+98/79 ANTIGENOS FEBRILES: CONTROL POSITIVO PROTEUS98/79 Antígenos Febriles: Control Positivo Brucella98/79	– 98/79	Website EUDAMED record Report an error
Randox	Northern Ireland	SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL POSITIVE)3 refs SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)2 refs SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)3 refs	B IVDR	Website EUDAMED record Report an error
Roche	Germany	CoaguChek XS PT Test PST PreciControl HTLV PreciControl HTLV-I/II	C, D IVDR	Website EUDAMED record Report an error
SD Biosensor EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ F S. pneumo & Legio Combo Ag Control C-F-PNLG-01C STANDARD™ H. pylori Ag Control C-HPY-01 STANDARD™ Legionella Ag Control C-LGN01G	B, C IVDR	Website EUDAMED record Report an error
SpeeDx EU representative : MedEnvoy Global BV (Netherlands)	Australia	PlexPCR Colour Compensation 1.0 Positive Control Flu/RSV/SARS 1.0 Positive Control HSV/VZV/TP 1.0	A, B IVDR	Website regulatory@speedx.com.au EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Quality Control Kit for Logilet HPV Panel QC401198/79 Quality Control Kit for Logilet Respiratory Pathogen Panel Quality Control Kit for Logilet STl Panel QC402198/79	B IVDR, 98/79	EUDAMED record Report an error
Acro Biotech EU representative : MedNet EC-REP GmbH (Germany)	United States	Gonorrhea Control98/79 Malaria P.f. /Pan Control SCMPN-D98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Autobio Diagnostics EU representative : QbD RepS BV (Belgium)	China	ToRCH IgG Control AutoLumo analyzer3 refs ToRCH IgM Control AutoLumo analyzer3 refs	C IVDR	info@autobio-diagnostics.com EUDAMED record Report an error
Diagnostics	Belgium	Bacterial Antigen polyvalent control + 590198/79 Bacterial Antigen polyvalent control - 590298/79	– 98/79	Website EUDAMED record Report an error
Hologic EU representative : Hologic BV (Belgium)	United States	Aptima Controls Kit Panther Fusion Internal Control-B3 refs	B, C IVDR	EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands)	China	2×1 mL (2 levels)98/79 6×1 mL (6 levels)98/79	– 98/79	EUDAMED record Report an error
Spinreact	Spain	BACTERIAL ANTIGENS No2 refs98/79 RPR-CARBON -CONTROL + No98/79	– 98/79	Website EUDAMED record Report an error
Genetic Signatures EU representative : mdi Europa GmbH (Germany)	Australia	EasyScreen™98/79 EasyScreen98/79 (no longer marketed)	– 98/79	Website RAQA@geneticsignatures.com EUDAMED record Report an error
Abacus Diagnostica	Finland	GenomEra® C. difficile Control Set CDX-20-56198/79	– 98/79	info@abacusdiagnostica.com EUDAMED record Report an error
bioMérieux	France	CELL Control R-GENE®98/79	– 98/79	EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetectTM SARS-CoV-2&Flu A&Flu B&RSV External Quality Control98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Cube Dx	Austria	IPC98/79	– 98/79	Website info@cubedx.com EUDAMED record Report an error
Human	Germany	HumaTex Febrile Antigens Control PC/NC98/79	– 98/79	Website EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany)	China	HP-Ag control98/79	– 98/79	EUDAMED record Report an error
Mpbio EU representative : MP Biomedicals Germany GmbH (Germany)	Singapore	MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test Controls98/79	– 98/79	EUDAMED record Report an error
Remel Europe EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	PATHODX HERPES TYPING CONTROL SLIDES	C IVDR	Website EUDAMED record Report an error
Sekisui Diagnostics EU representative : MDSS GmbH (Germany)	United States	OSOM® RSV/Adeno Control Kit 198E98/79	– 98/79	Website EUDAMED record Report an error
Techno-path Manufacturing	Ireland	Multichem ID-Chagas	C IVDR	Website EUDAMED record Report an error
Chemelex No model still on the market	Spain	Antígenos Bacterianos Control Negativo98/79 (no longer marketed) Antígenos Bacterianos Control Positivo98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error

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