411 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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EMIT 2000 VANCOMYCIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Diazo Total Bilirubin (D_TBil)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
FDA 510(k)
FDA Class 2
·Immunology
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTROL PLASMA P
FDA 510(k)
FDA Class 2
·Hematology
INNOVANCE D-DIMER, MODEL OPBP09
FDA 510(k)
FDA Class 2
·Hematology
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROTEIN S AC
FDA 510(k)
FDA Class 2
·Hematology
EMIT 2000 VANCOMYCIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOCI 8 CALIBRATOR, MODEL KC 646
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS ACUTE CARE D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
OT EQUATOR
FDA 510(k)
FDA Class 2
·Dental
SQA
FDA 510(k)
FDA Class 2
·Hematology
PORCELITE DUAL CURE CEMENT
FDA 510(k)
FDA Class 2
·Dental
SEALITE
FDA 510(k)
FDA Class 2
·Dental
KERR XR BOND
FDA 510(k)
FDA Class 2
·Dental
KERR CAVALITE
FDA 510(k)
FDA Class 2
·Dental
HEMO-SANITAS SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital