GKA

Product Code: GKA


Products Classified as GKA

2303Abnormal Hemoglobin QuantitationAbnormal Hemoglobin Assay.

Total Product Life Cycle (TPLC) Devices

2303Abnormal Hemoglobin QuantitationAbnormal Hemoglobin Assay.

Pre-market Notifications for GKA

K180762CAPI 3 HEMOGLOBIN(E)SEBIA
K171664Hemoglobin Variants System On Newborn Hemoglobin System With GDM And HbReview SoftwareBio-Rad Laboratories, Inc.
K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSEBIA
K112491SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2SEBIA
K091283CAPILLARYS NEONAT HB (PN 2006)SEBIA
K082227MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227SEBIA
K080911VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITHBIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
K052291CAPILLARY'S HEMOGLOBIN(E) (PN 2007)SEBIA
K051072BIO-RAD VARIANT NBS SICKLE CELL PROGRAMBIO-RAD LABORATORIES, INC.
K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367WALLAC OY
K040146INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMINTERLAB S.R.L.
K955283PRIMUS VARIANT SYSTEM PVS99PRIMUS CORP.
K840011RESOLVE-HBISOLAB, INC.

Global Unique Device Identification Database

00847817008351ABNORMAL HEMOGLOBIN QUANTITATION
00847817008344ABNORMAL HEMOGLOBIN QUANTITATION
00847817008313ABNORMAL HEMOGLOBIN QUANTITATION
00847817008306ABNORMAL HEMOGLOBIN QUANTITATION
00847817008283ABNORMAL HEMOGLOBIN QUANTITATION
00847817008276ABNORMAL HEMOGLOBIN QUANTITATION
00847817007354ABNORMAL HEMOGLOBIN QUANTITATION
06438147246137Abnormal Hemoglobin Quantitation
06438147246120Abnormal Hemoglobin Quantitation
06438147000814Abnormal Hemoglobin Quantitation
06438147000807Abnormal Hemoglobin Quantitation
06438147000791Abnormal Hemoglobin Quantitation
06438147000784Abnormal Hemoglobin Quantitation
05391516748193Abnormal Hemoglobin Quantitation
05391516748186Abnormal Hemoglobin Quantitation

Maude Adverse Events

VARIANT NBS SICKLE CELL PROGRAMBIO-RAD LABORATORIES INC.2013-12-16
VARIANTNBS WITH GDM 3.1 SOFTWAREBIO-RAD LABORATORIES2013-10-15
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