Home GUDID 00843876000503 CRYOcheck™ FVIII Inhibitor Kit
Primary DI 00843876000503
Brand CRYOcheck™ FVIII Inhibitor Kit
Company Precision Biologic Inc
Model CCIK08
Device description The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older.
Published 2019-03-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GGN Plasma, Coagulation Control GGP Test, Qualitative And Quantitative Factor Deficiency
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGN Plasma, Coagulation Control Hematology 2 GGP Test, Qualitative And Quantitative Factor Deficiency Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843876000503 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00843876000503 00843876000503 843876000503 0843876000503
GMDN Terms# Term, Definition table Term Definition Coagulation factor VIII inhibitor IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII inhibitor in a clinical specimen.
Regulatory Flags# DUNS number 244713368 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00843876000015 CRYOcheck™ Pooled Normal Plasma CCN-10 2016-09-23 00843876000022 CRYOcheck™ Pooled Normal Plasma CCN-15 2016-09-23 00843876000039 CRYOcheck™ Pooled Normal Plasma CCN10-10 2016-09-23 00843876000046 CRYOcheck™ Pooled Normal Plasma CCN-40 2016-09-23 00843876000053 CRYOcheck™ Reference Control Normal RCN-05 2016-09-23 00843876000060 CRYOcheck™ Reference Control Normal RCN-10 2016-09-23 00843876000077 CRYOcheck™ Abnormal 1 Reference Control ARP1-05 2016-09-23 00843876000084 CRYOcheck™ Abnormal 1 Reference Control ARP1-10 2016-09-23 00843876000091 CRYOcheck™ Abnormal 2 Reference Control ARP2-10 2016-09-23 00843876000190 CRYOcheck™ Normal Reference Plasma CCNRP-05 2016-09-23 00843876000206 CRYOcheck™ Normal Reference Plasma CCNRP-10 2016-09-23 00843876000213 CRYOcheck™ Factor II Deficient Plasma FDP02-10 2016-09-23 00843876000220 CRYOcheck™ Factor II Deficient Plasma FDP02-15 2016-09-23 00843876000237 CRYOcheck™ Factor V Deficient Plasma FDP05-10 2016-09-23 00843876000244 CRYOcheck™ Factor V Deficient Plasma FDP05-15 2016-09-23 00843876000251 CRYOcheck™ Factor VII Deficient Plasma FDP07-10 2016-09-23 00843876000268 CRYOcheck™ Factor VII Deficient Plasma FDP07-15 2016-09-23 00843876000275 CRYOcheck™ Factor VIII Deficient Plasma FDP08-10 2016-09-23 00843876000282 CRYOcheck™ Factor VIII Deficient Plasma FDP08-15 2016-09-23 00843876000299 CRYOcheck™ Factor VIII Deficient Plasma FDP08-40 2016-09-23
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