FDA.reportPublic FDA data

INNOVANCE Heparin

Primary DI
00630414639864
Brand
INNOVANCE Heparin
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873930
Catalog number
10873930
Device description
For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K162540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162540000INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbH2017-08-22KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639864006304146398646304146398640630414639864

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

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
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
03607450009064Stachrom® HeparinDIAGNOSTICA STAGOKFF2016-09-15
03607450006834STA® - Heparin ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450011784STA® - Liquid Anti-Xa 4DIAGNOSTICA STAGOKFF2016-09-15