Manufacturer

LGC Clinical Diagnostics

United StatesLegal entities : LGC Clinical Diagnostics, Inc.

Markets : Ireland · United States

Approvals : EU – class B · United States (FDA) – · class I, II

EU representative : MediMark Europe Sarl. (France)

12 categories, 148 models including 148 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Other virology controls - inf.imm.	W0105080804	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 156 Reagin (Syphilis) Positive Control 2015-009498/79 34 others 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 31 EBV IgM Positive Control 2000-003898/79 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 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 ACCURUN® 350 CMV DNA Positive Control 2020-0162 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 Chagas-1, 1x pos, 1mL SR160252 refs Optitrol Chagas-2, 1x pos, 1mL SR160352 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 Paediatric G negative, 2x neg, 2,5mL SR150253 refs Optitrol Parvo M SR150573 refs Optitrol Syphilis G SR111372 refs Optitrol ToRCH G Neg SR130193 refs Optitrol ToRCH M Neg SR130293 refs Optitrol VZV M SR150783 refs VALIDATE® Anti-SARS-CoV2 IgG Test Set 510mm98/79	B IVDR, 98/79	EUDAMED record Report an error
Multiconstituent controls - inf.imm.	W0105080807	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 25 others A21 Series 2000 CE 2000-003198/79 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 2 Series 2700 2000-002398/79 Accurun 2 Series 2700 2000-002498/79 ACCURUN 21 Multi-Marker control Series 1000 2000-0028 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® 2 Multi-Marker Positive Control Series 2900 2000-0080 Optitrol Blue SR11011 Optitrol Blue SR11013 Optitrol Blue SR11019 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 Orange, 1x pos, 1mL SR110613 refs Optitrol Paediatric G Pos SR150152 refs Optitrol Paediatric M Neg SR150032 refs Optitrol Red, 1x pos, 1mL SR110513 refs Optitrol SeroNeg, 2x neg, 1mL SR110003 refs Optitrol Yellow 4x5 mL SR110213 refs	B IVDR, 98/79	EUDAMED record Report an error
Hepatitis virus controls - inf.imm.	W0105080802	A113 Anti-HBc IgM 2015-006898/79 A115 Anti-HBc IgG 2015-007098/79 A127 Anti-Delta 2015-007998/79 A325 Series 200 HBV DNA 2020-009698/79 A325 Series 700 HBV DNA 2020-009898/79 17 others A51 Hepatitis Multi-Marker 2000-004098/79 A51 Hepatitis Multi-Marker 2000-004198/79 A52 Hepatitis Multi-Marker 2000-004398/79 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 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 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 ACCURUN117 Hepatitis B e Antigen Positive Control 2015-007198/79 Multichem ID HAV IgM Positive Control	B IVDR, 98/79	EUDAMED record Report an error
All infectious diseases controls - NAT	W0105080808	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 11 others 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	B IVDR	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	ACCURUN 130 Borrelia burgdorferi IgG Positive Control 2015-008098/79 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 342 CT/NG Nucleic Acid Positive Control Series 100 2025-006798/79 4 others ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 2025-006898/79 ACCURUN 501 C. difficile Control 2050-000898/79 ACCURUN 841 CT/NG Negative Control 2025-006198/79 ACCURUN® TV/MG Positive Molecular Control Kit 2020-0164	B IVDR, 98/79	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	A1 Negative Control 2010-001398/79 A1 Negative Control 2010-001598/79 A810 Negative Control 2010-002098/79 ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 2000-003998/79 ACCURUN 800 ToRCH Negative Control 2010-001898/79 3 others ACCURUN 803 Nucleic Acid Negative Quality Control 2035-000798/79 Multichem ID Multi-Marker Negative Control 2 x 4mL Multichem ID ToRCH IgG Negative Control 2010-002398/79	B IVDR, 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	VALIDATE® D-DIMER Test Set 902il98/79 VALIDATE® D-DIMER Test Set 902st98/79 VALIDATE® FIBRINOGEN Test Set 904il98/79 VALIDATE® FIBRINOGEN Test Set 904se98/79 VALIDATE® FIBRINOGEN Test Set 904st98/79 3 others VALIDATE® HEPARIN Test Set 903il98/79 VALIDATE® HEPARIN Test Set 903se98/79 VALIDATE® HEPARIN Test Set 903st98/79	– 98/79	EUDAMED record Report an error
Retrovirus controls - inf.imm.	W0105080803	A106 HIV-1 Ag 2015-006598/79 A106 HIV-1 Ag 2015-006698/79 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 1 other ACCURUN 315 Series 400 HIV-1 RNA 2020-009298/79	– 98/79	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	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 190 Chagas Positive Control 2015-009798/79 ACCURUN® Babesia Positive Molecular Control Kit 2020-0155	B IVDR, 98/79	EUDAMED record Report an error
Haemoglobin controls	W0103010504	VALIDATE® HbA1c Test Set 60598/79 VALIDATE® HbA1c Test Set 605sa98/79 VALIDATE® HbA1c Test Set 605to98/79	– 98/79	EUDAMED record Report an error
Bk virus	W0105040622	ACCURUN BKV Positive Control 2020-0209	B IVDR	EUDAMED record Report an error
Cytokines calibrators/controls	W01030608	VALIDATE® IL-6 Test Set 509ro98/79	– 98/79	EUDAMED record Report an error

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