16 results
·
7ms
·
Sources: EU EUDAMED, US FDA
PSA CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS CALCHECK PSA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THIRD GENERATION PSA CONTROL MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS HYBRITECH PSA QC, MODEL 37209
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
FDA 510(k)
FDA Class 1
·Pathology
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
FDA 510(k)
FDA Class 1
·Clinical Chemistry