Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV-GT Assay

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

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA

Kit, Dna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Dna Detection, Human Papillomavirus

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Antigen, Cancer 549

FDA classification

FDA Class 3 ·Antigen, Cancer 549

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification

FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Kit, Rna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Rna Detection, Human Papillomavirus

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA classification

FDA Class 3 ·Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification

FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

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

FDA classification

FDA Class 3 ·Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA classification

FDA Class 3 ·Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA classification

FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Device, Oxidase Test For Gonorrhea

FDA classification

FDA Class 3 ·Device, Oxidase Test For Gonorrhea