FDA.reportPublic FDA data

Hemochron Whole Blood Coagulation System

Primary DI
10711234202104
Brand
Hemochron Whole Blood Coagulation System
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
R-PRT400K
Catalog number
R-PRT400K
Device description
Kaolin Protamine Response Test 40 tubes/box
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KFFAssay, Heparin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFFAssay, HeparinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010193000HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYSInternational Technidyne Corp.2001-06-06KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10711234202104PrimaryGS10
00711234202107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071123420210410711234202104
00711234202107007112342021077112342021070711234202107

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor 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 determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710ilsd_ra.na@werfen.com

Regulatory Flags#

DUNS number
079299318
Device count
40
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10711234170342directCHECK ACT+ Whole Blood Control Level 1000DCGACT-1000DCGACT-12022-01-21
10711234170359directCHECK ACT+ Whole Blood Control, Level 2000DCGACT-2000DCGACT-22022-01-21
10711234170366directCHECK ACT-LR Whole Blood Controls, Level 1000DCGLR-1000DCGLR-12022-01-21
10711234170373directCHECK ACT-LR Whole Blood Control, Level 2000DCGLR-2000DCGLR-22022-01-21
10711234101230Hemochron Whole Blood Coagulation SystemPDAOPDAO2016-09-22
10711234102176Hemochron Whole Blood Coagulation SystemRQCHRTRQCHRT2016-09-22
10711234102183Hemochron Whole Blood Coagulation SystemRQCPRTRQCPRT2016-09-22
10711234102206Hemochron Whole Blood Coagulation SystemQCACTQCACT2016-09-22
10711234107027directCHECK Whole Blood ControlsDCJAPTT-NDCJAPTT-N2016-09-22
10711234107034directCHECK Whole Blood ControlsDCJAPTT-ADCJAPTT-A2016-09-22
10711234107041directCHECK Whole Blood ControlsDCJPT-ADCJPT-A2016-09-22
10711234107058directCHECK Whole Blood ControlsDCJACT-ADCJACT-A2016-09-22
10711234107065directCHECK Whole Blood ControlsDCJCPT-ADCJCPT-A2016-09-22
10711234107072directCHECK Whole Blood ControlsDCJCPT-NDCJCPT-N2016-09-22
10711234107089directCHECK Whole Blood ControlsDCJLR-ADCJLR-A2016-09-22
10711234107096HepCheck Whole Blood ControlDCP214-NDCP214-N2016-09-22
10711234107102HepCheck Whole Blood ControlDCP214-ADCP214-A2016-09-22
10711234170175directCHECK Whole Blood ControlsDCJCAPTT-ADCJCAPTT-A2016-09-22
10711234170229directCHECK Whole Blood ControlsDCJACT-NDCJACT-N2016-09-22
10711234170236directCHECK Whole Blood ControlsDCJPT-NDCJPT-N2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640259Dade Ci-Trol Heparin Control, LowSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00630414640365Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00630414639864INNOVANCE HeparinSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768019548Dade Ci-Trol Heparin Control, LowSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768019531Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768017438INNOVANCE HeparinSiemens Healthcare Diagnostics Products GmbHKFF2017-09-11
03663537008191BIOPHEN HEPARIN 6HYPHEN BIOMEDKFF2017-03-08
00842768003899Dade® Ci-Trol® Heparin Control, LowSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
00842768012945Berichrom® HeparinSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
08426950042211HemosIL HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950580324HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950088196Coatest HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950088967Coamatic HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950472476HemosIL Liquid HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950472490HemosIL LMW Heparin ControlsINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
10711234102176Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202036Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202081Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202098Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202111Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
00850201006031ACTICHROME Heparin (Anti-FIIa)Biomedica ADI Inc.KFF2016-09-20
00850201006079ACTICHROME HEPARIN (ANTI-FXA)Biomedica ADI Inc.KFF2016-09-20
03607450006827STA® - HBPM/LMWH ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450006841STA® - Hepanorm® HDIAGNOSTICA STAGOKFF2016-09-15
03607450006810STA® - Hepanorm® HBPM/LMWHDIAGNOSTICA STAGOKFF2016-09-15
03607450011791STA® - Liquid Anti-Xa 8DIAGNOSTICA STAGOKFF2016-09-15
03607450009064Stachrom® HeparinDIAGNOSTICA STAGOKFF2016-09-15
03607450006834STA® - Heparin ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450011784STA® - Liquid Anti-Xa 4DIAGNOSTICA STAGOKFF2016-09-15