FDA.reportPublic FDA data

HemosIL AcuStar Anti-B2GPI Domain 1

Primary DI
08426951298778
Brand
HemosIL AcuStar Anti-B2GPI Domain 1
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009800015
Catalog number
00009800015
Device description
1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):
Published
2018-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSVSystem,test,antibodies,b2 - glycoprotein i (b2 - gpi)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152875000QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsInova Diagnostics, Inc.2015-12-21MSV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426951298778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426951298778084269512987788426951298778

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-microglobulin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-2-microglobulin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify001. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days. 2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours. 3. Do not freeze.
Special Storage Condition, Specify001. Cartridge - Stability after opening on board the ACL AcuStar System is 60 days.2. Calibrator 1 & 2 - Stability after opening on board the ACL AcuStar System 8 hours.3. Do not freeze.
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
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
08426951011216HemosIL CL Anti-ß2 Glycoprotein-I IgMINSTRUMENTATION LABORATORY COMPANYMSV2026-04-08
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08426951289257QUANTA Flash® B2GP1 IgA ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289264QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289271QUANTA Flash® B2GP1 IgM ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
B24235B2SHUE010Anti-Beta 2 Glycoprotein Screen ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MSV2017-08-28
00845714002427Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002434Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002441Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002458Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
04250289503082AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-03-02
04250289503075AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-03-01
04250289502825AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502832AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502849AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289503099AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-12-09
00845714002939IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-10-27
04250289500852AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2016-09-27
04250289500869AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
04250289500951AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
00816879020229Autostat II Anti-B2-Glycoprotein I IgGHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020236Autostat II Anti-B2-Glycoprotein I IgMHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020243Autostat II Anti-B2-Glycoprotein I IgAHYCOR BIOMEDICAL LLCMSV2016-09-26
00845714004353IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-09-24
07333066014746EliA ß2-Glycoprotein I IgA WellPhadia ABMSV2016-09-23
07333066014753EliA ß2-Glycoprotein I IgG WellPhadia ABMSV2016-09-23
07333066014760EliA ß2-Glycoprotein I IgM WellPhadia ABMSV2016-09-23
08426950496977HemosIL AcuStar Anti-B2 Glycoprotein-I IgGINSTRUMENTATION LABORATORY COMPANYMSV2016-09-23