ReagentsInfectious diseasesControls/standards/calibrators - (infect. immunology/NAT)

Standards and calibrators - infect. immunology/NAT

EMDN code W01050809

11 manufacturers, 53 models including 53 on the market, 10 countries

On the market in Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 11

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

Manufacturer	Country	Registered models	Class	Contact
Ab Analitica	Italy	REALQUALITY RQ-ADENO STANDARD2 refs98/79 REALQUALITY RQ-CMV STANDARD2 refs98/79 REALQUALITY RQ-EBV STANDARD2 refs98/79 REALQUALITY RQ-ENTERO STANDARD2 refs98/79 REALQUALITY RQ-HHV 6 STANDARD2 refs98/79 6 others REALQUALITY RQ-HHV 7 STANDARD2 refs98/79 REALQUALITY RQ-HHV 8 STANDARD2 refs98/79 REALQUALITY RQ-HSV 1 STANDARD2 refs98/79 REALQUALITY RQ-HSV 2 STANDARD2 refs98/79 REALQUALITY RQ-JCV STANDARD2 refs98/79 REALQUALITY RQ-PARVO B19 STANDARD2 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
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
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland)	United States	Access anti-HAV Calibrator C39445 Access anti-HAV IgM Calibrator C39448 Access CMV IgG Calibrators A4070398/79 Access CMV IgM, Calibrators A4070698/79 Access HBc IgM (Reagent Pack)98/79 2 others Access RUBELLA IgM CALIBRATORS98/79 Access Toxo IgG Calibrators98/79	B IVDR, 98/79	Website 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
Abbott FDA	Ireland	Alinity 06S610198/79 Alinity SARS-CoV-2 IgG98/79 Alinity SARS-CoV-2 IgM98/79 ARCHITECT 06S600198/79 ARCHITECT SARS-CoV-2 IgG (Cal & Ctrl)98/79 1 other ARCHITECT SARS-CoV-2 IgM98/79	– 98/79	Website 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
Bio-Rad FDA	France	Access HCV Ab V3 Calibrators B3345998/79 Access HIV combo V2 Calibrators C2843198/79	– 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	Boditech H. pylori Ag Calibrator98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands)	China	6×1 mL (6 levels)98/79	– 98/79	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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