Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT .TB TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Anti-HBc

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold Plus Test

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 ·IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC 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 IgM

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

FDA Pre-Market Approval

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18 TEST

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS CALCHECK

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC IMMULITE ASSAY