FDA.reportPublic FDA data

CRYOcheck™ Platelet Lysate

Primary DI
00843876000435
Brand
CRYOcheck™ Platelet Lysate
Company
Precision Biologic Inc
Model
PNP-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
GGWTest, Time, Partial Thromboplastin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGWTest, Time, Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982062000CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10Precision Biologicals, Inc.1999-01-13GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843876000435PrimaryGS10
00843876010434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843876000435008438760004358438760004350843876000435
00843876010434008438760104348438760104340843876010434

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker IVD, reagentA 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.

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
00843876000206CRYOcheck™ Normal Reference PlasmaCCNRP-102016-09-23
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

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00630414640358Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414639758Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019562Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019555Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
13607450012627PTT-LADIAGNOSTICA STAGOGGW2021-03-23
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