Manufacturer

Vitassay

SpainLegal entities : VITASSAY HEALTHCARE S.L.U

Markets : Austria · Belgium · Bulgaria · Croatia · Cyprus · Czechia · Estonia · France · Greece · Iceland · Liechtenstein · Lithuania · Malta · Poland · Spain · Türkiye

Approvals : EU – class A

Website info@vitassay.com

35 categories, 63 models including 63 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
Respiratory tract infections - multiplex NA reagents	W0105070503	Vitassay qPCR AMB98/79 Vitassay qPCR HSM98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 8x8-well98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 96-well plate98/79 4 others Vitassay qPCR Primary Atypical Pneumonia, low profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 8x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 96-well plate98/79 Vitassay qPCR SARS-CoV-2 + Flu A + Flu B98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Vitassay qPCR Carbapenemase-generating Enterobacteriaceae98/79 Vitassay qPCR Gram-negative Nosocomial Agents I98/79 Vitassay qPCR Gram-negative Nosocomial Agents II98/79 Vitassay qPCR Vancomycin Resistance98/79 Vitassay qPCR β-lactamases + Colistin resistance98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Vitassay qPCR Primary Atypical Pneumonia Vitassay qPCR Sexually Transmitted Infections, 4 tubes x 24 test98/79 Vitassay qPCR Sexually Transmitted Infections, high profile, 16x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, high profile, 8x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, low profile, 16x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, low profile, 8x8-well strips98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Vitassay qPCR HCoV98/79 Vitassay qPCR SARS-CoV-298/79 Vitassay qPCR SARS-CoV-2 (ORF1ab, E & N)98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Vitassay qPCR Flu A + Flu B98/79 Vitassay qPCR Parainfluenza 1-3+2-498/79 Vitassay qPCR Type I/Flu98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Vitassay qPCR Clostridium difficile98/79 Vitassay qPCR Clostridium difficile toxins A+B98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Vitassay qPCR Dengue98/79 Vitassay qPCR Dengue 1+2+3+498/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Vitassay qPCR Flu + RSV + SARS CoV-2 N1/298/79 Vitassay qPCR Flu A + Flu B + RSV98/79	– 98/79	EUDAMED record Report an error
Multiple parasites panels	W01050704	Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia , low profile, 4x8-well strips98/79 Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia, high profile, 4x8-well strips98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Vitassay qPCR MTB complex98/79 Vitassay qPCR MTBC/NTM98/79	– 98/79	EUDAMED record Report an error
Other parasitology - NA reagents	W0105050399	Vitassay qPCR Blastocystis hominis + Dientamoeba fragilis98/79 Vitassay qPCR Dientamoeba fragilis98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	Vitassay qPCR High-Risk HPVs98/79 Vitassay qPCR HPV98/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Vitassay qPCR Japanese Encephalitis98/79 Vitassay qPCR Sapovirus98/79	– 98/79	EUDAMED record Report an error
Aspergillus - NA reagents	W0105060401	Vitassay qPCR Aspergillosis98/79	– 98/79	EUDAMED record Report an error
Astrovirus - NA reagents	W0105040530	Vitassay qPCR Astrovirus98/79	– 98/79	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	Vitassay qPCR BK98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Vitassay qPCR Bordetella pertussis + B. parapertussis+ B. holmesii98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Vitassay qPCR Chikungunya98/79	– 98/79	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	Vitassay qPCR E. coli pathotypes98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Vitassay qPCR NG CiproRes98/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Vitassay qPCR H. pylori ClariRes98/79	– 98/79	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	Vitassay qPCR Human Herpes Virus98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Vitassay qPCR MonkeyPox98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Vitassay qPCR Noro (I&II)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - NA reagents	W0105050309	Vitassay qPCR Malaria 598/79	– 98/79	EUDAMED record Report an error
Pneumocystis - NA reagents	W0105060405	Vitassay qPCR Pneumocystis jirovecii98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Vitassay Microorganism-NA isolation kit	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Vitassay qPCR RSV A + RSV B98/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Vitassay qPCR Rotavirus98/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Vitassay qPCR MRSA98/79	– 98/79	EUDAMED record Report an error
Tick borne diseases - multiplex NA reagents	W0105070507	Vitassay qPCR Tick Borne Disease98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Vitassay qPCR Zika+Dengue+Chikungunya98/79	– 98/79	EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents	W010501080302	Vitassay qPCR Macrolide Res- 23S rRNA Mutations98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	Vitassay qPCR West Nile98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Vitassay qPCR Zika98/79	– 98/79	EUDAMED record Report an error

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