CRYOcheck™ Normal Reference Plasma

Primary DI
00843876000206
Brand
CRYOcheck™ Normal Reference Plasma
Company
Precision Biologic Inc
Model
CCNRP-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
CodeName
GGNPlasma, Coagulation Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952622000CRYO CHECK NORMAL HUMAN REFERENCE PLASMAPrecision Biologicals, Inc.1995-10-30GGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843876000206PrimaryGS10
00843876010205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843876000206008438760002068438760002060843876000206
00843876010205008438760102058438760102050843876010205

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, calibratorA material which is used to establish known points of reference for 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.

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
00843876000015CRYOcheck™ Pooled Normal PlasmaCCN-102016-09-23
00843876000022CRYOcheck™ Pooled Normal PlasmaCCN-152016-09-23
00843876000039CRYOcheck™ Pooled Normal PlasmaCCN10-102016-09-23
00843876000046CRYOcheck™ Pooled Normal PlasmaCCN-402016-09-23
00843876000053CRYOcheck™ Reference Control NormalRCN-052016-09-23
00843876000060CRYOcheck™ Reference Control NormalRCN-102016-09-23
00843876000077CRYOcheck™ Abnormal 1 Reference ControlARP1-052016-09-23
00843876000084CRYOcheck™ Abnormal 1 Reference ControlARP1-102016-09-23
00843876000091CRYOcheck™ Abnormal 2 Reference ControlARP2-102016-09-23
00843876000190CRYOcheck™ Normal Reference PlasmaCCNRP-052016-09-23
00843876000213CRYOcheck™ Factor II Deficient PlasmaFDP02-102016-09-23
00843876000220CRYOcheck™ Factor II Deficient PlasmaFDP02-152016-09-23
00843876000237CRYOcheck™ Factor V Deficient PlasmaFDP05-102016-09-23
00843876000244CRYOcheck™ Factor V Deficient PlasmaFDP05-152016-09-23
00843876000251CRYOcheck™ Factor VII Deficient PlasmaFDP07-102016-09-23
00843876000268CRYOcheck™ Factor VII Deficient PlasmaFDP07-152016-09-23
00843876000275CRYOcheck™ Factor VIII Deficient PlasmaFDP08-102016-09-23
00843876000282CRYOcheck™ Factor VIII Deficient PlasmaFDP08-152016-09-23
00843876000299CRYOcheck™ Factor VIII Deficient PlasmaFDP08-402016-09-23
00843876000305CRYOcheck™ Factor IX Deficient PlasmaFDP09-102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
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08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
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08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19