366 results · 105ms · Sources: EU EUDAMED, US FDA

Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·COBAS INTEGRA CYCLOSPORINE

Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

DIMENSION DRUG CALIBRATOR, MODEL DC22B

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N LATEX STFR REAGENT

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML

FDA 510(k)
FDA Class 2 ·Microbiology

DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

FDA 510(k)
FDA Class 2 ·Microbiology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

FDA 510(k)
FDA Class 2 ·Hematology

URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

FDA 510(k)
FDA Class 2 ·Hematology

MODIFICATION OF N/T PROTEIN CONTROL SL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

STRATUS CS MYO CALPAK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry