FDA.reportPublic FDA data

INNOVANCE Antithrombin

Primary DI
00842768037146
Brand
INNOVANCE Antithrombin
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10709521
Catalog number
OPFH11
Device description
Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Published
2020-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBQANTITHROMBIN III QUANTITATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBQAntithrombin Iii QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081769000INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics2009-05-28JBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768037146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768037146008427680371468427680371460842768037146

GMDN Terms#

Term, Definition table
TermDefinition
Antithrombin III (ATIII) IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a chromogenic method.

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)242-3233XX@XX.XX
+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
00630414639673INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00630414639680INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00630414639796INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00195226000061HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2021-01-29
B1761480Antiserum to Human Antithrombin IIIKENT LABORATORIES INCJBQ2016-09-24
B1761484Antithrombin III RID plate packageKENT LABORATORIES INCJBQ2016-09-24
B1761485Antithrombin III RID plate packageKENT LABORATORIES INCJBQ2016-09-24
05051700010702Human Antithrombin III BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDJBQ2016-09-24
00842768013065Enzygnost® TAT microSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
00842768027017INNOVANCE® AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
00842768027024INNOVANCE® AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
08426950358701HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950056003HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950087571HemosIL Liquid AT SubstrateINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950440802HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950062325HemosIL AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950088936Coamatic LR AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950088868Coamatic AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
00850201006086ACTICHROME ATIII KITBiomedica ADI Inc.JBQ2016-09-20
03607450005684Liatest® AT IIIDIAGNOSTICA STAGOJBQ2016-09-15
03607450005967STA® - Stachrom® AT III 3DIAGNOSTICA STAGOJBQ2016-09-15
05391521420534TriniCHROM™ Antithrombin IIaTCOAG IRELAND LIMITEDJBQ2016-09-12
05391521420541TriniCHROM™ Antithrombin XaTCOAG IRELAND LIMITEDJBQ2016-09-12
03663537008207BIOPHEN Antithrombin 2.5HYPHEN BIOMEDJBQ2016-08-25
03663537008214BIOPHEN Antithrombin 5HYPHEN BIOMEDJBQ2016-08-25