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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

BIOPSY PIPETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SATURN 5 LASER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

LIAT STREP A ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana Strep Complete Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Solana GAS Assay, Solana instrument

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

Accula Strep A Test

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

AMPLIVUE GAS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE I STREP A

FDA 510(k)

FDA Class 2 ·Microbiology

LYRA DIRECT STREP ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry