Infectious diseasesControls/standards/calibrators - (infect. immunology/NAT)Standards and calibrators - infect. immunology/NAT

Standards and calibrators for all infections/ NAT

EMDN code W0105080908

5 manufacturers, 25 models including 25 on the market, 5 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 5

Manufacturer	Country	Registered models	Class	Contact
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
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
ElitechGroup FDA	Italy	ASPERGILLUS spp. ELITe Standard98/79 HEV ELITe Standard98/79 WNV ELITe Standard98/79	– 98/79	Website 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
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands)	Australia	PlexPCR Colour Compensation 1.0	A IVDR	Website regulatory@speedx.com.au EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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