517 results · 44ms · Sources: EU EUDAMED, US FDA

ELECSYS CALCHECK VITAMIN B12

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS TSH CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OXICOM CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

INTERLAB MICROCAL SERUM CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCESS OSTASE QC

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HCG CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

R&D GLU-LINE HEMATOLOGY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Filter, Intravascular, Cardiovascular

FDA classification
FDA Class 2 ·Filter, Intravascular, Cardiovascular

Coronavirus Antigen Detection Test System.

FDA classification
FDA Not Classified ·Coronavirus Antigen Detection Test System.

Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA classification
FDA Class 1 ·Single (Specified) Analyte Controls (Assayed And Unassayed)