HemosIL Liquid Antithrombin

Primary DI
08426950358701
Brand
HemosIL Liquid Antithrombin
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020030100
Catalog number
00020030100
Device description
HemosIL Liquid Antithrombin (4.5 mL)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K062431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062431000HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO2006-09-01JBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950358701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950358701084269503587018426950358701

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
Special Storage Condition, Specify00Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
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
08426950071068HemosIL Normal Control ASSAYED00020003110000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LR06260060200062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACT06260060300062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PT06260061100062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PT06260061400062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACT06260060500062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LR06260060600062600606002016-09-23
08426950573401HemosIL Routine Control Level 300020005800000200058002016-09-23
08426950660668HemosIL Abnormal Control 200020014000000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYED00020003210000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYED00020003310000200033102016-09-23
08426950087595HemosIL Calibration Plasma00020003700000200037002016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTT06260060100062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 182 2650 6382 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 282 2668 6382 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 200020012000000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTT06260061600062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PT06260061700062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PT06260060400062600604002016-09-23
08426950453062HemosIL Special Test Control Level 100020011000000200110002016-09-23

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
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
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