FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB

FDA 510(k)

FDA Class 2 ·Anesthesiology

ON THE SPOT CANDIDASURE

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDATE(R) SUPER

FDA 510(k)

FDA Class 2 ·Microbiology

EI-CANDIDA ENZYME IMMUNOASSAY EI1001

FDA 510(k)

FDA Class 2 ·Microbiology

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)

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB-M 2.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

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 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

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

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA