FDA.reportPublic FDA data

Enzygnost® TAT micro

Primary DI
00842768013065
Brand
Enzygnost® TAT micro
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446632
Catalog number
OWMG15
Device description
Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma
Published
2016-09-24
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
K880700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880700000ENZYGNOST(R) TAT REAGENTSBehring Diagnostics, Inc.1988-04-27JBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013065008427680130658427680130650842768013065

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VIII IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII 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
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
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24
00842768004056Dade® Ci-Trol® Coagulation Control Level 110445731B4244-102016-09-24

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
00842768037146INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2020-05-07
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
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