Home GUDID 00843876000053 CRYOcheck™ Reference Control Normal
Primary DI 00843876000053
Brand CRYOcheck™ Reference Control Normal
Company Precision Biologic Inc
Model RCN-05
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 GIZ Plasma, Control, Normal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GIZ Plasma, Control, Normal Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843876000053 Primary GS1 0 00843876010052 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 00843876000053 00843876000053 843876000053 0843876000053 00843876010052 00843876010052 843876010052 0843876010052
GMDN Terms# Term, Definition table Term Definition Multiple coagulation factor IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components 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 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 00843876000305 CRYOcheck™ Factor IX Deficient Plasma FDP09-10 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10859394006061 PlasmaCon N R 2 DIAGNOSTICS, INC. GIZ 2016-11-15 10859394006078 PlasmaCon L1 R 2 DIAGNOSTICS, INC. GIZ 2016-11-15 10859394006085 PlasmaCon L2 R 2 DIAGNOSTICS, INC. GIZ 2016-11-15 00842768006821 Berichrom® Heparin UF Control 1 Siemens Healthcare Diagnostics Products GmbH GIZ 2016-09-24 00842768006876 Berichrom® Heparin LMW Control 1 Siemens Healthcare Diagnostics Products GmbH GIZ 2016-09-24 00843876000060 CRYOcheck™ Reference Control Normal Precision Biologic Inc GIZ 2016-09-23 00850201006147 LAtrol NORMAL CONTROL PLASMA Biomedica ADI Inc. GIZ 2016-09-20 00845275000559 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GIZ 2016-09-16 13607450006756 STA® - Unicalibrator DIAGNOSTICA STAGO GIZ 2016-09-15 15391521420777 TriniCHECK™ D-Dimer 1 TCOAG IRELAND LIMITED GIZ 2016-09-12 M52553010 Coagulation S.A.C.-1 (Specialty Assay Control) HELENA LABORATORIES CORPORATION GIZ 2016-09-07 00855360006243 REAADS Coagulation Control 1 CORGENIX MEDICAL CORPORATION GIZ 2016-07-14