Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TD CYCLOSPORINE AND METABOLITES SERUM ASSAY

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

FDA classification

FDA Class 2 ·Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Gas Control Unit, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Gas Control Unit, Cardiopulmonary Bypass

PHENOBARBITAL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS METHAQUALONE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

T3 RIA (PEG) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UCP HOME DRUG SCREENING TEST CUPS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VANCOMYCIN FPIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEFOTAXIME 30 MCG. SENSI-DISC.

FDA 510(k)

FDA Class 2 ·Microbiology

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology