HemosIL UF Heparin Controls

Primary DI
08426950478683
Brand
HemosIL UF Heparin Controls
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020300300
Catalog number
00020300300
Device description
HemosIL UF Heparin Controls
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
GNNANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1-24, B 1-6

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090209000HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory CO2009-06-02KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950478683PrimaryGS10
18426950478680Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950478683084269504786838426950478683
1842695047868018426950478680

GMDN Terms#

Term, Definition table
TermDefinition
Heparin anti-Xa IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened controls 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
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
00815696021235George King SDN Control KitGEORGE KING BIO-MEDICAL, INCGNN2020-06-26
08426950573401HemosIL Routine Control Level 3INSTRUMENTATION LABORATORY COMPANYGNN2016-09-23
08426950573388HemosIL Routine Control Level 1INSTRUMENTATION LABORATORY COMPANYGNN2016-09-23
08426950573395HemosIL Routine Control Level 2INSTRUMENTATION LABORATORY COMPANYGNN2016-09-23
B110CB33060Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GNN2016-09-12
B110CB33120Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GNN2016-09-12
B110CBG33200Coxsackie B1-B6 IgG ControlBion Enterprises, Ltd.GNN2016-09-12
B110CBN33100Coxsackie B1-B6 Negative ControlBion Enterprises, Ltd.GNN2016-09-12