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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Unit, Beta, Radiation, Ophthalmic

FDA classification

FDA Class 2 ·Unit, Beta, Radiation, Ophthalmic