497 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROM PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Immunoassay For Detection Of Amniotic Fluid Protein(S).
FDA classification
FDA Class 1
·Immunoassay For Detection Of Amniotic Fluid Protein(S).
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CANNABINOID URINE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS CALCHECK TESTOSTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPUS HCG CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS TOXO IGG CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HDL-CHOLESTEROL CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUDIT MICROCV T-UPTAKE LINEARITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONE-TROL HEMOGLOBIN A1C CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS CALCHECK CEA
FDA 510(k)
FDA Class 1
·Clinical Chemistry