FDA.reportPublic FDA data

GEM Hematocrit Evaluator 2

Primary DI
08426950573678
Brand
GEM Hematocrit Evaluator 2
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00025000105
Catalog number
00025000105
Device description
GEM Hematocrit Evaluator 2
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
GLKCONTROL, HEMATOCRIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLKControl, HematocritHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093623000GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TOInstrumentation Laboratory CO2010-06-18CIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950573678PrimaryGS10
18426950573675Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950573678084269505736788426950573678
1842695057367518426950573675

GMDN Terms#

Term, Definition table
TermDefinition
Red blood cell count 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 red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment Temperature15 Degrees Celsius25 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
08426951293827ChemSTAT Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293834ChemSTAT Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293841ChemSTAT Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293858GEM ChemSTAT critPVP 1-4INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
00831829000137HemataChek, Low, Normal, High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000144HemataChek, Low & Normal ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000151HemataChek, Normal & High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000168HemataChek Low Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000182HemataChek Normal Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000205HemataChek High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00630414121789RAPIDQC® Hct Level ASiemens Healthcare Diagnostics Inc.GLK2016-09-24
00630414121796RAPIDQC® Hct Level BSiemens Healthcare Diagnostics Inc.GLK2016-09-24
08426950452058GEM critCheckINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950511526IL critPVPINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046653Hct Check - Low LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046660Hct Check - High LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446231GEM CVP (Calibration Valuation Product) 3 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446248GEM CVP (Calibration Valuation Product) 4 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573661GEM Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573685GEM Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
06944413801875Blood Gas and Chemistry AnalyzerEdan Instruments, Inc.GLK2016-09-01
06944413802018 Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
06944413802025Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
08718734960423EurotrolEurotrol B.V.GLK2016-08-26
08718734960430EurotrolEurotrol B.V.GLK2016-08-26
08718734960454EurotrolEurotrol B.V.GLK2016-08-26
08718734960478EurotrolEurotrol B.V.GLK2016-08-26