FDA.reportPublic FDA data

ACTICHROME Heparin (Anti-FIIa)

Primary DI
00850201006031
Brand
ACTICHROME Heparin (Anti-FIIa)
Company
Biomedica ADI Inc.
Model
820
Catalog number
820
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
00850201006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850201006031008502010060318502010060310850201006031

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor IIa (thrombin) IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor IIa (thrombin) in a clinical specimen, using a chromogenic method.

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
00850201006048IMUBIND PLASMA PAI-1 ELISA8228222016-09-20
00850201006055ACTICLOT dPT8248242016-09-20
00850201006062DVVtest 258258252016-09-20
00850201006079ACTICHROME HEPARIN (ANTI-FXA)8328322016-09-20
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
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