FDA.reportPublic FDA data

Chrono-log

Primary DI
00811476010017
Brand
Chrono-log
Company
CHRONO-LOG CORP
Model
299-4
Device description
vW Reference Plasma Deficient
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
00811476011212PackageGS13In Commercial Distribution
00811476011229PackageGS14In Commercial Distribution
00811476011236PackageGS15In Commercial Distribution
00811476011243PackageGS16In Commercial Distribution
00811476011250PackageGS17In Commercial Distribution
00811476011267PackageGS18In Commercial Distribution
00811476011274PackageGS12In Commercial Distribution
811476010932PackageGS19In Commercial Distribution
00811476010017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811476011212008114760112128114760112120811476011212
00811476011229008114760112298114760112290811476011229
00811476011236008114760112368114760112360811476011236
00811476011243008114760112438114760112430811476011243
00811476011250008114760112508114760112500811476011250
00811476011267008114760112678114760112670811476011267
00811476011274008114760112748114760112740811476011274
811476010932008114760109328114760109320811476010932
00811476010017008114760100178114760100170811476010017

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
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11