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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 411

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

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

FDA Pre-Market Approval

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

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 ANALYSTICS E170

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM ON COBAS E 601

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 601

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, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740044848·Quantia Ferritin/Myoglobin/IgE Control

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740030100·Quantia IgE Calibrators

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740156367·Quantia IgE Calibrators

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740156404·Quantia Ferritin/Myoglobin/IgE Control

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740054243·Quantia Immunoglobulin E

ARCHITECT

FDA UDI

ABBOTT LABORATORIES·00380740156282·Quantia Immunoglobulin E

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAS HCG-CHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPT CERTAINTY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry