HemosIL Routine Control Level 1

Primary DI
08426950573388
Brand
HemosIL Routine Control Level 1
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020005600
Catalog number
00020005600
Device description
HemosIL Routine Control Level 1
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
K082859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082859000HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYEDInstrumentation Laboratory CO2008-12-19GGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950573388PrimaryGS10
18426950573385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950573388084269505733888426950573388
1842695057338518426950573385

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components 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
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
00815696021235George King SDN Control KitGEORGE KING BIO-MEDICAL, INCGNN2020-06-26
08426950573401HemosIL Routine Control Level 3INSTRUMENTATION LABORATORY COMPANYGNN2016-09-23
08426950478683HemosIL UF Heparin ControlsINSTRUMENTATION 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