10,000 results
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81ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
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
PARAMAX SALICYLATE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
MICROSTREP PLUS PANEL, VANCOMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
FDA 510(k)
FDA Class 2
·Hematology
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
OPUS TROPONIN I (CTN) TEST MODULES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
EMIT-AMD AMIKACIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BCT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
N PROTEIN STANDARD SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N PROTEIN STANDARD UY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry