FDA.reportPublic FDA data

HemosIL Low Fibrinogen Control

Primary DI
08426950451976
Brand
HemosIL Low Fibrinogen Control
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020004200
Catalog number
00020004200
Device description
HemosIL Low Fibrinogen Control
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
KQJSystem, Fibrinogen Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQJSystem, Fibrinogen DeterminationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950451976PrimaryGS10
18426950451973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950451976084269504519768426950451976
1842695045197318426950451973

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened control is 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
10
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
00630414639734Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639741Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639901Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640150Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640266Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640273Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640372Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018541Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018503Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019845Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019524Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019517Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019494Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019500Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640532Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
G0561009890Calcium ChlorideBio/Data CorporationKQJ2023-08-30
00859394006040FibrotekR 2 DIAGNOSTICS, INC.KQJ2016-11-15
05051700010726Human Fibrinogen BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDKQJ2016-09-24
00842768003936Dade® Data-Fi® Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003943Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003950Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003981Dade® Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768007170Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017865Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017872Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768039416Dade® CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
08426950087618HemosIL Fibrinogen-C XLINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950478676HemosIL Fibrinogen-CINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
13607450006749STA® - Fibrinogen 5DIAGNOSTICA STAGOKQJ2016-09-15
15391521420364TriniCLOT™ Fibrinogen 6 mLTCOAG IRELAND LIMITEDKQJ2016-09-12