Home GUDID 00843876000480 CRYOcheck™ LA Sure™
Primary DI 00843876000480
Brand CRYOcheck™ LA Sure™
Company Precision Biologic Inc
Model SUR-10
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GIR Reagent, Russel Viper Venom
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GIR Reagent, Russel Viper Venom Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843876000480 Primary GS1 0 00843876010489 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00843876000480 00843876000480 843876000480 0843876000480 00843876010489 00843876010489 843876010489 0843876010489
GMDN Terms# Term, Definition table Term Definition Lupus anticoagulant marker IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.
Regulatory Flags# DUNS number 244713368 Device count 25 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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