Manufacturer

Rapid Labs

United Kingdom (ex Northern Ireland)Legal entities : Rapid Labs Ltd

Markets : Germany · Greece · Italy · Poland · Spain

Approvals : EU – class A

EU representative : Advena Limited (Malta)

Website info@rapidlabs.co.uk

65 categories, 328 models including 328 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Controls infectious immunology - RT & POC	W0105094001	Adenovirus + RSV Control D-S-CARC98/79 Adenovirus Control D-PL-CADE98/79 Adenovirus pneumoniae Antigen Control D-S-CADE98/79 Adenovirus/Rotavirus Control D-PL-CAR98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 75 others Adenovirus/RSV/Influenza A+B Control D-S-CARI98/79 Astrovirus Control D-PL-CAS98/79 Brucella Abortus Control2 refs98/79 C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Device – Feces D-CDGTABD1098/79 Campylobacter Control D-PL-CCAM98/79 Candida Albicans Control D-PL-CCA98/79 Chagas Control D-P-CCHA98/79 Chikungunya control D-L-CCHIGM98/79 Chikungunya IgG/IgM Antibody Control D-PL-CCHIGM98/79 Clostridium difficile GDH + Toxin A + Toxin B Control D-PL-CCD98/79 Clostridium difficile GDH Control D-PL-CCDG98/79 Clostridium difficile Toxin A+ Toxin B Control D-PL-CCDT98/79 COVID-19 Ag/Influenza A+B Control98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 Antigen Control98/79 Cryptosporidium Antigen Control D-PL-CCRY98/79 Cryptosporidium Control D-L-CCRY98/79 Dengue IgG/IgM Control D-L-CDEGM98/79 Dengue IgG/IgM Control D-P-FIDEN98/79 Dengue NS1 Control4 refs98/79 Entamoeba Histolytica Control D-PL-CEH98/79 Entamoeba/Giardia/Crypto Control2 refs98/79 FLU A+B Control98/79 Giardia Lamblia Control D-PL-CGL98/79 Gonorrhea Control98/79 H. pylori Antigen Control D-P-FIHPG98/79 H.pylori Ag Control D-S-CHPG98/79 H.pylori Antibody Control D-L-CHPB98/79 H.pylori Antigen Control D-PL-CHPG98/79 HPV Antigen Control D-S-CHPV98/79 Human Metapneumovirus Antigen Control D-PL-HMPV98/79 Influenza A+B Control D-S-CFLAB98/79 Influenza A/B+H1N1 Control98/79 Legionella pneumophila Control5 refs98/79 Malaria P.f. Control D-P-CMPF98/79 Malaria P.f./P.v. Control D-P-CMPV98/79 Malaria P.f./P.v./Pan Control D-P-CMPVF98/79 Malaria P.f./Pan Control D-P-CMPN98/79 Monkeypox Virus Antibody Control D-L-CMPOX98/79 Monkeypox Virus Antigen Control D-PL-CMPOXAG98/79 MONO Control D-L-CMONO98/79 Multiplex Respiratory Antigen Control D-S-CRT998/79 Mycoplasma Pneumoniae Antigen Control D-S-CMP98/79 Mycoplasma pneumoniae IgG/IgM Control D-L-CMPGM98/79 Mycoplasma pneumoniae IgM Control D-L-CMPM98/79 Norovirus Control D-PL-CNOR98/79 Norovirus/Rotavirus/Adenovirus Control D-PL-CNRA98/79 Rotavirus and Adenovirus Combo Control D-P-FIRAC98/79 Rotavirus Control D-PL-CROT98/79 RSV Control D-S-CRSV98/79 RSV Control D-S-FIRSV98/79 RSV/Influenza A+B Control D-S-CRI98/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae/L. pneumophila Control98/79 Salmonella paratyphi Antigen Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 Antigen Control (Swab)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 Scrub Typhus IgG/IgM Control2 refs98/79 Strep A Control D-L-CSTA98/79 Strep A Control D-P-FISTA98/79 Strep B Control D-L-CSTB98/79 Streptococcus pneumoniae Control3 refs98/79 Syphilis Control D-L-CSYP98/79 Syphilis Control D-P-CSYP98/79 Syphilis Control D-P-FISYP98/79 Tetanus Control D-PL-CTET98/79 Trichomonas Vaginalis Control D-PL-CTV98/79 Tuberculosis Control98/79 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control D-L-CZIB98/79 Zika NS1 Control98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Test Device-Feces D-FIADFD1098/79 Adenovirus Antigen Test Device-Feces D-FIADFD2598/79 Adenovirus pneumoniae Antigen Test Device- Nasopharyngeal Swab D-FIADNSD2098/79 Adenovirus Rapid Test Device-Feces D-RADOD1098/79 Adenovirus Rapid Test Device-Feces D-RADOD2598/79 31 others Astrovirus Ag Test Device-Feces D-FIASTD1098/79 Astrovirus Ag Test Device-Feces D-FIASTD2598/79 Chikungunya IgM Rapid Test Device-WB/S/P98/79 Dengue Combo Rapid Test Device-WB/S/P98/79 Dengue IgG, IgM and NS1 Combo Test Device-Fingerstick WB, WB/S/P2 refs98/79 Dengue IgG/IgM Test Device -WB/S/P3 refs98/79 Dengue NS1 Test Device -WB/S/P2 refs98/79 Ebola IgG/IgM Rapid Test Device D-EBLGMD2598/79 Enterovirus Antigen Rapid Test-feces D-ENTOD1098/79 EV71 IgM Rapid Test Device (Whole Blood/Serum/Plasma)98/79 Giardia Lamblia Rapid Test Device - Feces D-GLD1098/79 Giardia Lamblia Rapid Test Device – Feces D-GL10D98/79 Hantavirus IgG/IgM Rapid Test Device D-HANT4098/79 HMPV Rapid Test Device-Nasopharyngeal Swab98/79 HMPV Test Device-Nasopharyngeal Swab98/79 HPIV Test Device-Nasopharyngeal Swab98/79 HSV 1 IgG/IgM Test Device-Finger Prick WB, WB/S/P2 refs98/79 HSV 2 IgG/IgM Test Device-Finger Prick WB, WB/S/P2 refs98/79 Human Parainfluenza Virus (HPIV) Rapid Test Device-Nasopharyngeal Swab98/79 Measles IgG/IgM Rapid Test-WB/S/P98/79 Norovirus Rapid Test Device-Feces D-RNOROD1098/79 Norovirus Rapid Test Device-Feces D-RNOROD2598/79 Norovirus Test Device-Feces D-FINOROD1098/79 Norovirus Test Device-Feces D-FINOROD2598/79 Rhinovirus Rapid Test Device-Nasopharyngeal Swab D-RHVD2098/79 Rotavirus Rapid Test Device-Feces D-RROTAGD1098/79 Rotavirus Rapid Test Device-Feces D-RROTAGD2598/79 Rotavirus Test Device-Feces D-FIROTD1098/79 Rotavirus Test Device-Feces D-FIROTD2598/79 Varicella Zoster Virus lgM Rapid Test Device-WB/S/P98/79 West Nile Virus IgG/IgM Rapid Test Device D-WMGMD2098/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Campylobacter Rapid Test Device – Feces D-CAMD1098/79 Candida Albicans Rapid Test Device-Swab D-CAND0198/79 Candida Albicans Rapid Test Device-Swab D-CAND1098/79 Candida Albicans Rapid Test Device-Swab D-CAND2098/79 CARBA-5 Rapid Test-Culture98/79 26 others Cholera Ag O139 Rapid Test Device – Feces98/79 Gardnerella vaginalis Antigen Rapid Test Device98/79 H. pylori Antibody Rapid Test Device-WB/S/P2 refs98/79 H. pylori Antigen Rapid Test-Feces D-HPAGC1098/79 H. pylori Antigen Test Device-Feces D-FIHPD1098/79 H. pylori Antigen Test Device-Feces D-FIHPD2598/79 H. pylori Rapid Test -Tartar D-HPTD1098/79 Leptospira IgG/IgM Test Device-Fingerstick WB, WB/S/P2 refs98/79 Leptospira IgM Rapid Test Device-WB/S/P98/79 Mycobacterium tuberculosis Antigen Rapid Test Device-Sputum Culture98/79 Mycoplasma pneumoniae Antigen Test Device -Throat Swab98/79 Salmonella typhi and paratyphi B Antigen Rapid Test Device - Feces98/79 Scrub Typhus IgG/IgM Rapid Test Device – WB/S/P98/79 Scrub Typhus IgG/IgM Test Device-Fingerstick WB, WB/S/P2 refs98/79 Tetanus IgG Test Device-Fingerstick WB, WB/S/P2 refs98/79 Tuberculosis (TB) Rapid Test Device – WB/S/P98/79 Tuberculosis IgG/IgM Rapid Test Device-WB/S/P98/79 Tuberculosis Rapid Test Strip-WB/S/P98/79 Typhoid Test Device -Fingerstick WB, WB/S/P2 refs98/79 Vibrio cholerae O1/O139 Combo Rapid Tes tDevice - Feces98/79 Vibrio cholerae O1 (VC O1) Rapid Test Device - Feces98/79 Vibrio Cholerae O1 Inaba Rapid Test Device98/79 Vibrio Cholerae O1 Ogawa Rapid Test Device98/79 Vibrio cholerae O139 (VC O139) Rapid Test Device - Feces98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test (Feces)98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Device98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Adenovirus pneumoniae and RSV Combo Test Device- Nasopharyngeal Swab D-FIARNSD2098/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Device-Nasopharyngeal Swab D-FIARID2098/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test Device-Swab98/79 20 others Adenovirus/RSV/HMPV/Influenza A+B/COVID-19 Combo Rapid Test Device-Swab98/79 Dengue/Zika/Chikungunya Combo Rapid Test Device-WB/S/P98/79 Multiplex 5 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 6 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 7 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 8 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 9 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test Device-Feces D-NRAAED1098/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD0198/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD2598/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD1098/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD2598/79 RSV/HMPV Combo Rapid Test Device-Nasopharyngeal Swab98/79 RSV/HMPV/Adenovirus/HPIV/Influenza A+B Combo Rapid Test Device98/79 SARS-CoV-2 & Inﬂuenza A+B & RSV & Adenovirus & M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Device-Nasopharyngeal Swab2 refs98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test-Nasopharyngeal Swab98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	Adenovirus & RSV Combo Rapid Test Device – Nasopharyngeal Swab D-ARD1098/79 Adenovirus Antigen Rapid Test Device – Swab D-ADAGD2098/79 Adenovirus antigen Test Device -Feces D-FIADED2598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Device - Nasopharyngeal Swab D-ARID1098/79 COVID-19 Antigen Rapid Test Device – Oral Fluid98/79 6 others COVID-19 IgG Rapid Test Device – WB/S/P98/79 COVID-19,Flu A+B &RSV Combo Rapid Test -Nasopharyngeal swab98/79 RSV & Influenza A+B Combo Rapid Test Device – Swab/Nasal D-RID1098/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Device – Nasal Swab2 refs98/79 SARS-CoV-2 Antigen Rapid Test Device – Oral Fluid98/79 SARS-CoV-2 IgG/ IgM Rapid Test Device (WB/S/P)98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 antibodies - total	W0105040302	HSV 1/2 IgG Rapid Test Device – S/P98/79 HSV 1/2 IgG Rapid Test Device – WB/S/P98/79 HSV 1/2 IgG/IgM Combo Rapid Test Device – S/P98/79 HSV 1/2 IgG/IgM Combo Rapid Test Device – WB/S/P98/79 HSV 1/2 IgG/IgM Rapid Test Device – S/P98/79 4 others HSV 1/2 IgG/IgM Rapid Test Device – WB/S/P98/79 HSV 1/2 IgM Rapid Test Device - WB/S/P2 refs98/79 HSV-1 IgG/IgM Rapid Test -WB/S/P98/79 HSV-2 IgG/IgM Rapid Test -WB/S/P98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	Salmonella paratyphi Antigen Rapid Test Device -Feces98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Device – WB/S/P98/79 Salmonella typhi Antigen Rapid Test Device – Feces98/79 Typhoid Rapid Test Device – WB/S/P98/79 Typhoid IgG/IgM Rapid Tes Device– WB/S/P98/79 3 others Typhoid Rapid Test Device – S/P2 refs98/79 Typhoid Rapid Test Strip - WB/S/P98/79 Typhoid Rapid Test Strip – S/P98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test Device -S/P D-RTPD4098/79 Syphilis Rapid Test Device – S/P D-TPSPD4098/79 Syphilis Rapid Test Device – WB/S/P2 refs98/79 Syphilis Rapid Test Strip – S/P D-TPSPS5098/79 Syphilis Rapid Test Strip – WB/S/P2 refs98/79 2 others Syphilis Test Device -WB/S/P3 refs98/79 Syphilis Test Kit-human serum or plasma D-CITPK4098/79	– 98/79	EUDAMED record Report an error
Abo sera	W0103030102	Anti-A Monoclonal BG-A1098/79 Anti-A,B Monoclonal BG-AB1098/79 Anti-A,B,AB，D (IgG&IgM) Kit Reagent BG-ABOD1098/79 Anti-A,B,D (IgG&IgM) Kit BG-ABD1098/79 Anti-B Monoclonal BG-B1098/79 1 other Anti-D Monoclonal (lgG+lgM)98/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium difficile GDH Test Device-Feces D-FICLOSD1098/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD2598/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD1098/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD2598/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD1098/79 1 other Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD2598/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A Rapid Test Device -Swab/Nasal Aspirate98/79 Influenza A Rapid Test Strip – Swab/Nasal Aspirate98/79 Influenza A+B Rapid Test Device – Swab/Nasal Aspirate98/79 Influenza A+B Rapid Test Device-Swab D-RINFABD2598/79 Influenza A+B Rapid Test Strip – Swab/Nasal Aspirate2 refs98/79 1 other Influenza A+B Test Device -Swab D-FIIABD2098/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chagas Rapid Test Device D-RLCHAD4098/79 Entamoeba+Giardia+Crypto Combo Rapid Test Device-Feces98/79 Entamoeba/Giardia/Crypto Rapid Test Device (1 Window) -Feces98/79 Filariasis IgG/IgM rapid Test Device – WB/S/P98/79 Filariasis IgG/IgM Test Device-Fingerstick WB, WB/S/P2 refs98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika antigen Test Device -WB/S/P98/79 Zika IgG/IgM & NS1 Combo Rapid Test Device – WB/S/P98/79 Zika IgG/IgM Rapid Test Device – WB/S/P98/79 Zika IgM Test Device -WB/S/P98/79 Zika NS1 Rapid Test Device -WB/S/P98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Rapid Test Device -WB/S/P98/79 Dengue Combo(NS1+IgG/IgM)+Chikungunya IgG/IgM+Zika IgG/IgM Rapid Test Device98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Device D-DGMCMD2098/79 Dengue NS1 Rapid Test Device-WB/S/P98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	COVID-19 Ag/Influenza A+B Combo Test Device – Nasopharyngeal Swab98/79 RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Device-Swab98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG/IgM Test Device -Finger Prick WB, WB/S/P2 refs98/79 COVID-19 S-RBD IgG Antibody Test Device -WB/S/P2 refs98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Devie-WB/S/P98/79	– 98/79	EUDAMED record Report an error
Ebv antibodies - other	W010504040199	EBNA IgG Rapid Test Device – WB/S/P98/79 EBV VCA and EBNA IgG Combo Rapid Test Device – WB/S/P98/79 EBV VCA IgG Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H.pylori antibody Rapid Test Device – S/P D-HPABD4098/79 H.pylori Antibody Rapid Test Device – WB/S/P98/79 H.pylori Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Fluorescence Immunoassay Analyzer3 refs Lateral Flow Reader Plus Portable Lateral Flow (LF) Reader	A IVDR	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antibody Rapid Test--Whole Blood/Serum/Plasma D-MPOXD2598/79 Monkeypox Virus Antigen Rapid Test-Whole Blood/Serum/Plasma D-MPOXAGD2598/79 Monkeypox Virus Antigen Test Device-Fingerstick WB, WB/S/P/Rash Exudate Swab/Throat Swab98/79	– 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	Norovirus, Rotavirus and Adenovirus Combo Rapid Test Device - D-NRAD1098/79 Rotavirus & Adenovirus Combo Rapid Test Device – Feces D-ROAAGD2098/79 Rotavirus Rapid Test Device – Feces D-ROTAGD2098/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria P.f./P.v. Rapid Test Device - WB98/79 Malaria P.f./P.v. Rapid Test Device -WB/S/P98/79 Malaria P.f./Pan Rapid Test Device – WB98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f./P.v./Pan Rapid Test Device – WB98/79 Malaria P.f./P.v./Pan Test Device--WB2 refs98/79 Malaria Pf Rapid Test Strip – WB98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Device -Throat Swab3 refs98/79 Strep A RTC Rapid Test Device – Throat Swab98/79 Strep A Test Device -Swab D-FISTRAS2098/79	– 98/79	EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers- instruments	W02010701	Cup Reader RL-CD-1A Uric Acid Meter RL-AUAR-1002 refs Urine Analyzer RL-UA-5A2 refs	A IVDR	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Rapid Test Device – Feces D-ADOD2598/79 Astrovirus Rapid Test Device – Feces D-ASTD1098/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	C. difficile GDH+ Toxin A +Toxin B Combo Rapid Test -Faeces D-CLOSGTD1098/79 C.difficile Toxin A +Toxin B Combo Rapid Test Device – Feces D-CDTABD1098/79	– 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	C.difficile GDH Rapid Test Device – Feces D-CLOSD2098/79 Clostridium difficile GDH Test Device -Feces D-FICDGD1098/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	Chagas Rapid Test Device – S/P D-CHAD4098/79 Chagas Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen Rapid Test Device-Nasopharyngeal Swab2 refs98/79 SARS-CoV-2 Antigen Rapid Test Device – Swab2 refs98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Cryptosporidium Ag and Giardia Lamblia Ag Combo Test Device-Feces D-FICRYGLD1098/79 Cryptosporidium Ag and Giardia Lamblia Ag Combo Test Device-Feces D-FICRYGLD2598/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test Cassette Device - Swab98/79 Gonorrhea Rapid Test Device – Swab98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H. pylori Antigen Rapid Test Device -Feces D-RHPAGD2598/79 H. pylori Antigen Rapid Test strip-Feces D-HPAGS2598/79	– 98/79	EUDAMED record Report an error
Hbsag - RT & POC	W0105090201	HAV IgM Rapid Test Device – WB/S/P98/79 HAV IgM Rapid Test S/P D-HAVMD2098/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	HPV Antigen Rapid Test -Cervical Swab D-HPVCSD2598/79 HPV Antigen Rapid Test Device – Cervical Swab D-HPVD2098/79	– 98/79	EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC	W0105099003	EBV VCA IgA Rapid Test Device-WB/S/P98/79 MONO Rapid Test Device -WB/S/P2 refs98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Mycoplasma Pneumoniae IgG/Ig M Rapid Test Device – WB/S/P98/79 Mycoplasma Pneumoniae IgM Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Rapid Test Device-Nasopharyngeal swab/Nasal Aspirate98/79 RSV Test Device -Swab D-FIRSVD2098/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test Device – Swab D-STRBD2098/79 Strep B Rapid Test Strip – Swab D-STRBS2098/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus pneumoniae antigen Rapid Test Device – Urine98/79 Streptococcus pneumoniae Test Device -Urine2 refs98/79	– 98/79	EUDAMED record Report an error
Trichomonas	W0105050210	Trichomonas Vaginalis Rapid Test Device D-TVD1098/79 Trichomonas Vaginalis Rapid Test Device – Swab D-TRVAD1098/79	– 98/79	EUDAMED record Report an error
Abo grouping cells	W0103030101	Anti-A Monoclonal BG-A1098/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automatic Chemiluminescence Immunoassay Analyzer	A IVDR	EUDAMED record Report an error
Blood glucose meters	W0201060102	Blood Glucose Meter II D-BGM22 refs	A IVDR	EUDAMED record Report an error
Brucella	W0105011701	Brucella Abortus Antigen Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Rapid Test Device – S/P D-CHIKGMD4098/79	– 98/79	EUDAMED record Report an error
Cryptococcus	W0105060303	Cryptococcus Antigen Rapid Test Device – WB/S/P/CSF98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Rapid Test Device – WB/P98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue Combo Rapid Test Device D-DAGMD2098/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	Enterovirus 71 Ag Test Device-Feces2 refs98/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	HPV 16/18 qPCR Kit-Cervical Swab2 refs98/79	– 98/79	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	HB Hemoglobin Strip D-HBMS5098/79	– 98/79	EUDAMED record Report an error
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Sickle Cell Rapid Test Device-WB98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	HAV IgG/IgM Combo Rapid Test Device – WB/S/P98/79	– 98/79	EUDAMED record Report an error
Hev antibody (total)	W0105020503	HEV IgG/IgM Rapid Test Device D-HEVD2098/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Test Device -Urine2 refs98/79	– 98/79	EUDAMED record Report an error
Legionella antigen detection	W0105010501	Legionella pneumophila Rapid Test Device – Urine98/79	– 98/79	EUDAMED record Report an error
Leishmania	W0105050205	Leishmania IgG/IgM Rapid Test Device D-LEIGMD2098/79	– 98/79	EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other	W02020699	Hb Hemoglobin Test Meter RL-HBM-1A2 refs	A IVDR	EUDAMED record Report an error
Rubella virus igm	W0105040103	Rubella Ig M Rapid Test Device – Serum/Plasma D-RUBMD1098/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Widal Kit Salmonella Ha,Hb,Hc,Hd,OA,OB,OC,OD. +tve/-tve Control98/79	– 98/79	EUDAMED record Report an error
Shigella	W0105011714	Shigella Rapid Test Device D-SHID2098/79	– 98/79	EUDAMED record Report an error
Tetanus (clostridium t.)	W0105011709	Tetanus Rapid Test Device – WB/S/P2 refs98/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody (total)	W0105050101	Toxoplasmosis IgG/ Ig M Rapid Test Strip – WB/S/ P98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Cholesterol Meter RL-CHOM-1A2 refs	A IVDR	EUDAMED record Report an error

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