231 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
FDA 510(k)
FDA Class 2
·Immunology
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
FDA 510(k)
FDA Class 2
·Hematology
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Computer, Oxygen-Uptake
FDA classification
FDA Class 2
·Computer, Oxygen-Uptake
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
FDA 510(k)
FDA Class 2
·Microbiology
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV
Bcr/Abl1 Monitoring Test
FDA classification
FDA Class 2
·Bcr/Abl1 Monitoring Test