Manufacturer

Certest

SpainLegal entities : CERTEST BIOTEC S.L.

First countries of placing on the market declared in EUDAMED : Slovenia, Spain

47 categories, 95 models including 95 on the market, 1 country

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
Virology - RT & POC - other	W0105099099	CerTest Adenovirus3 refs CerTest Adenovirus Resp.3 refs CerTest Astrovirus3 refs CerTest Influenza A+B+RSV3 refs CerTest Influenza A+B+RSV+Adeno Resp3 refs 9 others CerTest Norovirus3 refs CerTest Norovirus GI+GII3 refs CerTest Rota+Adeno+Astro+Noro3 refs CerTest ROTA+ADENO+NORO3 refs CerTest Rotavirus3 refs CerTest Rotavirus+Adenovirus3 refs CerTest Rotavirus+Adenovirus+Astrovirus3 refs CerTest Rotavirus+Norovirus GI/GII3 refs CerTest RSV+Adenovirus Resp.3 refs	B IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	VIASURE Adenovirus, Metapneumovirus & Bocavirus Real Time PCR Detection Kit3 refs VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit2 refs98/79 VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit3 refs VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for BD MAX™ System VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit3 refs 5 others VIASURE Respiratory Panel VII Real Time PCR Detection Kit3 refs VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit3 refs VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit3 refs	B, C IVDR, 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	CerTest Crypto3 refs CerTest Crypto+Giardia3 refs CerTest Crypto+Giardia+Entamoeba3 refs CerTest Entamoeba3 refs CerTest Giardia+3 refs	B IVDR	EUDAMED record Report an error
Other parasitology - NA reagents	W0105050399	VIASURE Blastocystis hominis + Dientamoeba fragilis Real Time PCR Detection Kit3 refs VIASURE Cryptosporidium, Giardia & E. histolytica Real Time PCR Detection Kit3 refs VIASURE Dientamoeba fragilis Real Time PCR Detection Kit3 refs VIASURE Entamoeba dispar Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	VIASURE ADV, CMV, EBV & PB19 Real Time PCR Detection Kit3 refs VIASURE Monkeypox virus Real Time PCR Detection Kit3 refs VIASURE Mumps, Enterovirus & Parechovirus Real Time PCR Detection Kit3 refs VIASURE Sapovirus Real Time PCR Detection Kit3 refs	B, C IVDR	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	CerTest Campylobacter3 refs Certest ResisCheck® Carbapenemases CerTest S. pneumoniae+Legionella	B, C IVDR	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	VIASURE Clostridium difficile Real Time PCR Detection Kit3 refs VIASURE Clostridium difficile toxB Real Time PCR Detection Kit3 refs VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	CerTest C. difficile GDH+Toxin A+B3 refs CerTest Clostridium difficile antigen GDH3 refs CerTest Clostridium difficile Toxin A+B3 refs	B IVDR	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	VIASURE Flu A + B Real Time PCR Detection Kit3 refs VIASURE Flu Typing II Real Time PCR Detection Kit3 refs VIASURE Parainfluenza Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	VIASURE V-Flex VIASURE V-Lab96 Cycler VIASURE V-Quick32	A IVDR	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	VIASURE Adenovirus plus Real Time PCR Detection Kit3 refs VIASURE Adenovirus q Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	CerTest EHEC VT1 Positive Control98/79 CerTest EHEC VT2 Positive Control98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	VIASURE Coronavirus 229E, NL63, OC43 & HKU1 Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2 Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	VIASURE Salmonella, Campylobacter & Shigella/EIEC Real Time PCR Detection Kit3 refs VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX™ System VIASURE N. gonorrhoeae, C. trachomatis & M. genitalium Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents	W010501080302	VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit3 refs VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)	B, C IVDR	EUDAMED record Report an error
Astrovirus - NA reagents	W0105040530	VIASURE Astrovirus Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	VIASURE BK virus q Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	VIASURE Bordetella Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
C.difficile toxin a/b detection	W0105011802	CerTest CLIA Clostridium difficile Toxin A/B Ag2 refs	B IVDR	EUDAMED record Report an error
Candida auris - NA reagents	W0105060404	VIASURE Candida auris Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Chagas - NA reagents	W0105050302	VIASURE Trypanosoma cruzi Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	VIASURE Chikungunya Virus Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	CerTest SARS-CoV-2+ Flu A + Flu B3 refs	B IVDR	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	CerTest SARS-CoV-23 refs	B IVDR	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	VIASURE EBV q Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	Universal Turbilatex® Sample Vial	A IVDR	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	CerTest H. pylori3 refs	B IVDR	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	CerTest Influenza A+B3 refs	B IVDR	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	CerTest Legionella	C IVDR	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	VIASURE H. influenzae, N. meningitidis & S. pneumoniae Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	VIASURE Norovirus GI + GII Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 refs	B IVDR	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	VIASURE Viral Meningitis Panel Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	VIASURE RSV A + B Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Rotavirus	W0105040606	CerTest CLIA Rotavirus Ag2 refs	B IVDR	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	VIASURE Rotavirus Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	CerTest RSV3 refs	B IVDR	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	VIASURE Group A Streptococcus Real Time PCR Detection Kit3 refs	B IVDR	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	CerTest S. pneumoniae	C IVDR	EUDAMED record Report an error
Toxoplasma - NA reagents	W0105050105	VIASURE Toxoplasma gondii Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	VIASURE Tropical Panel Plus Real Time PCR Detection Kit3 refs	C IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software	W02079092	VIASURE V-Smart Offline	A IVDR	EUDAMED record Report an error

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