FDA.reportPublic FDA data

Stachrom® Heparin

Primary DI
03607450009064
Brand
Stachrom® Heparin
Company
DIAGNOSTICA STAGO
Model
00906
Published
2016-09-15
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925433000THE STACHROM HEPARIN ASSAY KITAmerican Bioproducts Co.1995-05-23KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450009064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450009064036074500090643607450009064

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
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
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

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
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
03607450006834STA® - Heparin ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450011784STA® - Liquid Anti-Xa 4DIAGNOSTICA STAGOKFF2016-09-15