FDA.reportPublic FDA data

Chrono-log

Primary DI
00811476010000
Brand
Chrono-log
Company
CHRONO-LOG CORP
Model
299-1
Device description
Ristocetin 7.5 mg/Vial
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K945414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945414000RISTOCETIN COFACTOR ASSAY KITChrono-Log Corp.1995-01-11GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811476011052PackageGS13In Commercial Distribution
00811476011069PackageGS14In Commercial Distribution
00811476011076PackageGS15In Commercial Distribution
00811476011083PackageGS16In Commercial Distribution
00811476011090PackageGS17In Commercial Distribution
00811476011106PackageGS18In Commercial Distribution
00811476011137PackageGS12In Commercial Distribution
811476010949PackageGS19In Commercial Distribution
00811476010000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811476011052008114760110528114760110520811476011052
00811476011069008114760110698114760110690811476011069
00811476011076008114760110768114760110760811476011076
00811476011083008114760110838114760110830811476011083
00811476011090008114760110908114760110900811476011090
00811476011106008114760111068114760111060811476011106
00811476011137008114760111378114760111370811476011137
811476010949008114760109498114760109490811476010949
00811476010000008114760100008114760100000811476010000

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study 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 evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-853-1130chronolog@chronolog.com

Regulatory Flags#

DUNS number
002353696
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811476011007CHRONO-LOGAGGRO/LINK WBA Software2023-06-21
00811476011021CHRONO-LOGAGGRO/LINK8 Software2023-06-21
00811476011045CHRONO-LOGvW CoFactor Software2023-06-21
00811476011663CHRONO-LOGAGGRO/LINK Opti8 Software2023-06-21
00811476011670CHRONO-LOGvW CoFactor Opti8 Software2023-06-21
00811476010246Chrono-log490490-2D2016-10-11
00811476010253Chrono-log490490-X2016-10-11
00811476010369Chrono-log590590-2D2016-10-11
00811476010376Chrono-log590590-X2016-10-11
00811476010383Chrono-log5915912016-10-11
00811476010390Chrono-log591A591A2016-10-11
00811476010406Chrono-log5925922016-10-11
00811476010413Chrono-log592592-X2016-10-11
00811476010420Chrono-log592A592A2016-10-11
00811476010437Chrono-log592A592A-X2016-10-11
00811476010482Chrono-log700700-22016-10-11
00811476010499Chrono-log700700-X2016-10-11
00811476010956Chrono-log490490-4D2016-10-11
00811476010963Chrono-log590590-4D2016-10-11
00811476010987Chrono-log490 4+490 4+2016-12-28

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
00811476010017Chrono-logCHRONO-LOG CORPGGP2016-10-11