FDA.reportPublic FDA data

ELECTRACHROME Factor VIII

Primary DI
08426950101697
Brand
ELECTRACHROME Factor VIII
Company
INSTRUMENTATION LABORATORY COMPANY
Model
049730503
Catalog number
049730503
Device description
ELECTRACHROME Factor VIII
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
GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981038000COAMATIC FACTOR VIIIInstrumentation Laboratory CO1998-04-16GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950101697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950101697084269501016978426950101697

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VIII IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened reagents 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
18006780710techsupport@werfen.com
18006780710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
Device count
1
Kit
true
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
00843876000602CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2025-11-25
00630414320366BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00842768018800BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00195226001129HemosIL Chromogenic Factor IXINSTRUMENTATION LABORATORY COMPANYGGP2024-07-09
00630414640433vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-29
00630414639437Berichrom a2-AntiplasminSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639628Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639710Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639826INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640389Factor VIII Chromogenic AssaySiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640457Protein S AcSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640655Protein C ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00842768006661vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2023-06-16
00843876000565CRYOcheck Chromogenic Factor IXPrecision Biologic IncGGP2023-01-06
G0561012580Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561012691vW Normal Reference PlasmaBio/Data CorporationGGP2022-03-23
G0561012701vW Abnormal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561015951Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561030251vW Factor Assay (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
G0561064261vW Normal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561067301vW Select Kit (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
00843876000558CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2020-07-27
08600000686048VFERamco Laboratories, Inc.GGP2019-03-26
00843876000503CRYOcheck™ FVIII Inhibitor KitPrecision Biologic IncGGP2019-03-25
00842768039522INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2018-11-15
03607450007374STA® - Staclot® Protein C 3DIAGNOSTICA STAGOGGP2017-12-06
10629009010000VisuLize Factor FVIII Antigen KitAffinity Biologicals IncGGP2017-04-28
10629009020009VisuLize Factor FIX Antigen KitAffinity Biologicals IncGGP2017-04-28
00859394006095ThromboTek PSeR 2 DIAGNOSTICS, INC.GGP2016-11-15
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11