Home GUDID 00843876000558 CRYOcheck Factor VIII Chromogenic
Primary DI 00843876000558
Brand CRYOcheck Factor VIII Chromogenic
Company Precision Biologic Inc
Model CCCF08
Catalog number CCCF08
Device description CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
Published 2020-07-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GGP Test, Qualitative And Quantitative Factor Deficiency
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGP Test, Qualitative And Quantitative Factor Deficiency Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843876000558 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 00843876000558 00843876000558 843876000558 0843876000558
GMDN Terms# Term, Definition table Term Definition Coagulation factor VIII IVD, kit, chromogenic A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method.
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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