Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBC IGM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM AUSAB

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS ANTI-HBE ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBeAg

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

Go North Medical AB

Importer

🇸🇪 Sweden

Elisa, Antibody, West Nile Virus

FDA classification

FDA Class 2 ·Elisa, Antibody, West Nile Virus

GO EYEWEAR, S.A.

Authorized representative

🇵🇹 Portugal

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Antibodies, Anti-Actin, Anti-Smooth Muscle

FDA classification

FDA Class 2 ·Antibodies, Anti-Actin, Anti-Smooth Muscle

Babesia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Babesia Spp. Serological Reagents

Bartonella Spp. Serological Reagents

FDA classification

FDA Not Classified ·Bartonella Spp. Serological Reagents

Probe & go Labordiagnostica GmbH

Importer

🇩🇪 Germany

LABORATORIOS PHARMA & GO S.A

Importer

🇪🇸 Spain

Orientia Spp. (Scrub Typhus) Serological Reagents

FDA classification

FDA Not Classified ·Orientia Spp. (Scrub Typhus) Serological Reagents