FDA.reportPublic FDA data

HemosIL Q.F.A. Thrombin (Bovine) - 2 mL

Primary DI
08426950573500
Brand
HemosIL Q.F.A. Thrombin (Bovine) - 2 mL
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020301800
Catalog number
00020301800
Device description
HemosIL Q.F.A. Thrombin (Bovine) - 2 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
GISTEST, FIBRINOGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GISTest, FibrinogenHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963902000QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.1996-11-29GIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950573500PrimaryGS10
18426950573507Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950573500084269505735008426950573500
1842695057350718426950573507

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened reagent 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
18006780710techsupport@werfen.com
18006780710techsupport.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
00816426021075K-ASSAY® Fibrinogen ReagentKAMIYA BIOMEDICAL COMPANY, LLCGIS2017-01-13
00816426021082K-ASSAY® Fibrinogen CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2017-01-13
10859394006191FIB CalibratorR 2 DIAGNOSTICS, INC.GIS2016-11-15
00859394006040FibrotekR 2 DIAGNOSTICS, INC.GIS2016-11-15
00817089020672DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020689DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020696DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
08426950573494HemosIL Q.F.A. Thrombin (Bovine) - 5 mLINSTRUMENTATION LABORATORY COMPANYGIS2016-09-23
00845275000580Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000597Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000627Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000825Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000856Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00816426020214K-ASSAY® Fibrinogen Reagent + CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020351K-ASSAY® Fibrinogen Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020658K-ASSAY® Fibrinogen CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16