HemosIL Thrombin Time

Primary DI
08426950058366
Brand
HemosIL Thrombin Time
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009758515
Catalog number
00009758515
Device description
HemosIL Thrombin Time
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
GJATEST, THROMBIN TIME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJATest, Thrombin TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862301000IL SYSTEM 810, ACL AND THE REAGENT SETSInstrumentation Laboratory CO1986-09-03GJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950058366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950058366084269500583668426950058366

GMDN Terms#

Term, Definition table
TermDefinition
Thrombin time (TT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the thrombin time (TT) of a clinical specimen using a clotting 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
00630414639635Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2024-03-25
10859394006054T-tekR 2 DIAGNOSTICS, INC.GJA2016-11-15
00842768012716Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
00842768013102BC Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
13607450006114STA® - Thrombin 2DIAGNOSTICA STAGOGJA2016-09-15
13607450006695STA® - Thrombin 10DIAGNOSTICA STAGOGJA2016-09-15
M52553770Thrombin Clotting Time ReagentHELENA LABORATORIES CORPORATIONGJA2016-09-07