CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Alizarin Sulfonate, Calcium

FDA classification

FDA Class 2 ·Alizarin Sulfonate, Calcium

Bacillus Subtilis Microbiology Assay, Tobramycin

FDA classification

FDA Class 2 ·Bacillus Subtilis Microbiology Assay, Tobramycin

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0

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

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