FDA.reportPublic FDA data

CRYOcheck™ Clot S™

Primary DI
00843876000428
Brand
CRYOcheck™ Clot S™
Company
Precision Biologic Inc
Model
CCS-30
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GGPTest, Qualitative And Quantitative Factor Deficiency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043571000CRYOCHECK CLOT SPrecision Biologic, Inc.2005-03-18GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843876000428PrimaryGS10
00843876010427Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843876000428008438760004288438760004280843876000428
00843876010427008438760104278438760104270843876010427

GMDN Terms#

Term, Definition table
TermDefinition
Protein S IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a clotting method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
244713368
Device count
5
Kit
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843876000602CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2025-11-25
00630414320366BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00842768018800BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00195226001129HemosIL Chromogenic Factor IXINSTRUMENTATION LABORATORY COMPANYGGP2024-07-09
00630414640433vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-29
00630414639437Berichrom a2-AntiplasminSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639628Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639710Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639826INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640389Factor VIII Chromogenic AssaySiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640457Protein S AcSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640655Protein C ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00842768006661vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2023-06-16
00843876000565CRYOcheck Chromogenic Factor IXPrecision Biologic IncGGP2023-01-06
G0561012580Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561012691vW Normal Reference PlasmaBio/Data CorporationGGP2022-03-23
G0561012701vW Abnormal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561015951Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561030251vW Factor Assay (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
G0561064261vW Normal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561067301vW Select Kit (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
00843876000558CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2020-07-27
08600000686048VFERamco Laboratories, Inc.GGP2019-03-26
00843876000503CRYOcheck™ FVIII Inhibitor KitPrecision Biologic IncGGP2019-03-25
00842768039522INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2018-11-15
03607450007374STA® - Staclot® Protein C 3DIAGNOSTICA STAGOGGP2017-12-06
10629009010000VisuLize Factor FVIII Antigen KitAffinity Biologicals IncGGP2017-04-28
10629009020009VisuLize Factor FIX Antigen KitAffinity Biologicals IncGGP2017-04-28
00859394006095ThromboTek PSeR 2 DIAGNOSTICS, INC.GGP2016-11-15
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11