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

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA classification

FDA Class 3 ·Prostrate Cancer Genes Nucleic Acid Amplification Test System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Gonococcal Antibody Tests

FDA classification

FDA Class 3 ·Gonococcal Antibody Tests

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA classification

FDA Class 3 ·Antigen(Complexed),Prostate Specific,(Cpsa)

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

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test