Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology

Active Anthrax DetectTM Plus Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

simpli-COLLECT STI Test

FDA 510(k)

FDA Class 2 ·Microbiology

The SensiTox B. anthracis Toxin Test

FDA 510(k)

FDA Class 2 ·Microbiology

Calibrator For Red-Cell And White-Cell Counting

FDA classification

FDA Class 2 ·Calibrator For Red-Cell And White-Cell Counting

Obturator, For Endoscope

FDA classification

FDA Class 2 ·Obturator, For Endoscope

Scissors For Cystoscope

FDA classification

FDA Class 2 ·Scissors For Cystoscope

Radioimmunoassay For Cyclosporine

FDA classification

FDA Class 2 ·Radioimmunoassay For Cyclosporine

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

FDA classification

FDA Class 2 ·Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Extravascular Support For An Arteriovenous Fistula For Vascular Access

FDA classification

FDA Class 2 ·Extravascular Support For An Arteriovenous Fistula For Vascular Access

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV Test