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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

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

Kit, Rna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Rna Detection, Human Papillomavirus

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)

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA classification

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

Device, Oxidase Test For Gonorrhea

FDA classification

FDA Class 3 ·Device, Oxidase Test For Gonorrhea

Gonococcal Antibody Tests

FDA classification

FDA Class 3 ·Gonococcal Antibody Tests

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

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA classification

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

Hiv Self-Tests

FDA classification

FDA Class 3 ·Hiv Self-Tests

Test, Anti-Tumor Cell Susceptibility

FDA classification

FDA Class 3 ·Test, Anti-Tumor Cell Susceptibility

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

FDA classification

FDA Class 3 ·Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Test, Urea Adult And Pediatric (Breath),

FDA classification

FDA Class 3 ·Test, Urea Adult And Pediatric (Breath),

Hepatitis Viral B Dna Detection

FDA classification

FDA Class 3 ·Hepatitis Viral B Dna Detection

Hepatitis Delta Serological Reagents

FDA classification

FDA Class 3 ·Hepatitis Delta Serological Reagents