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