665 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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PERKINELMER 226 SAMPLE COLLECTION DEVICES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS RBC FOLATE HEMOLYZED REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS HCG STAT CLASET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
FDA 510(k)
FDA Class 2
·Immunology
TINA-QUANT ALPHA-1 ANTITRYPSIN
FDA 510(k)
FDA Class 2
·Immunology
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
ELECSYS CORTISOL CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ROCHE DIAGNOSTICS CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
FDA 510(k)
FDA Class 2
·Hematology
ELECSYS INSULIN CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CALIBRATOR FOR AUTOMATED SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ELECSYS CA 125 II CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS FSH CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry