FDA.reportPublic FDA data

ACTICHROME HEPARIN (ANTI-FXA)

Primary DI
00850201006079
Brand
ACTICHROME HEPARIN (ANTI-FXA)
Company
Biomedica ADI Inc.
Model
832
Catalog number
832
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KFFASSAY, HEPARIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFFAssay, HeparinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850201006079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850201006079008502010060798502010060790850201006079

GMDN Terms#

Term, Definition table
TermDefinition
Heparin anti-Xa IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080600606
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850201006017DVVtest 108108102016-09-20
00850201006024DVVconfirm 58158152016-09-20
00850201006031ACTICHROME Heparin (Anti-FIIa)8208202016-09-20
00850201006048IMUBIND PLASMA PAI-1 ELISA8228222016-09-20
00850201006055ACTICLOT dPT8248242016-09-20
00850201006062DVVtest 258258252016-09-20
00850201006086ACTICHROME ATIII KIT8388382016-09-20
00850201006093IMUBIND vWF ACTIVITY ELISA8858852016-09-20
00850201006109SPECTROLYSE PAI-11012011012012016-09-20
00850201006116ACTISCREEN XL-FDP800DB800DB2016-09-20
00850201006123DVVconfirm 10815L815L2016-09-20
00850201006130LAtrol ABNORMAL CONTROL PLASMA816A816A2016-09-20
00850201006147LAtrol NORMAL CONTROL PLASMA816N816N2016-09-20
00850201006154ACTICLOT PROTEIN S843L843L2016-09-20
00850201006161ACTICLOT C KITACC-45ACC-452016-09-20
00850201006178DIMERTEST Latex assayDLHK7DLHK72016-09-20
00850201006185XL-FDP agglutination reagent800DB-LX800DB-LX2016-09-20
00850201006192ACTICLOT Protein C Resistance Kit8408402016-09-20
00850201006208ACTICLOT Protein C Resistance control plasmas840C840C2016-09-20

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
10711234202104Hemochron 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
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