10,000 results · 170ms · Sources: EU EUDAMED, US FDA

AXSYM CK-MB

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CARESIDE AST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)

FDA 510(k)
FDA Class 2 ·Immunology

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA 13 ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FIRST RESPONSE PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AncestryDNA Saliva Collection Kit

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CPK REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RIGHTEST Blood Glucose Monitoring System Max Tel

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VENOJECT AUTOSEP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIOTROL CREATININE H.P. REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BICARBONATE (CO2) REAGENT-2 VIAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology