409 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
FDA 510(k)
FDA Class 2
·Hematology
GLYCABEN
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
FDA 510(k)
FDA Class 2
·Hematology
INFINITY HBA KIT, MODELS 537-A, 537-B
FDA 510(k)
FDA Class 2
·Hematology
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
BIO-RAD D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
Lucica Glycated Albumin-L
FDA 510(k)
FDA Class 2
·Hematology
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
FDA 510(k)
FDA Class 2
·Hematology
GLYCO HB QUIK COLUMN PROCEDURE
FDA 510(k)
FDA Class 2
·Hematology
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
FDA 510(k)
FDA Class 2
·Hematology
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
FDA 510(k)
FDA Class 2
·Hematology
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
GLYCACOR
FDA 510(k)
FDA Class 2
·Hematology
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
LANCER GLYCOSYLATED HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
GLYCOHEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
FDA 510(k)
FDA Class 2
·Hematology
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology