RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

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

FDA Pre-Market Approval

FDA Class 2 ·ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·UBIS 5000 BONE SONOMETER

Sepsis ImmunoScore

FDA 510(k)

FDA Class 2 ·General Hospital

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TOTAL PSA

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ADAPPTE ARTIFICIAL TEAR

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER