FDA.reportPublic FDA data

ImmunoWELL Cardiolipin (IgM) Test

Primary DI
00613745031002
Brand
ImmunoWELL Cardiolipin (IgM) Test
Company
GenBio
Model
800-3100
Catalog number
3100
Device description
The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIDSystem, Test, Anticardiolipin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920401000IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTGeneral Biometrics, Inc.1992-08-20MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745031002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745031002006137450310026137450310020613745031002

GMDN Terms#

Term, Definition table
TermDefinition
Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-592-9300support@genbio.com

Regulatory Flags#

DUNS number
940425333
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
00613745003948ONtrack Amp83544402026-06-08
00613745003955ONtrack Prep83544502026-06-08
00613745003962HISTO SPOT ® HLA AB Reagent KitB3728198728198RUO2026-06-08
00613745003979HISTO SPOT ® HLA AB ID CLASS II – AD1B3728196728196RUO2026-06-08
00613745003986HISTO SPOT ® HLA AB ID CLASS IIB3728101728101RUO2026-06-08
00613745003993HISTO SPOT ® HLA AB ID CLASS IB3728100728100RUO2026-06-08
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)73337622026-05-15
00613745003870NGSgo®-AmpX v2 Enhancer707000112026-05-06
00613745003887NGSgo®-LibrX End Prep Enzyme200200512026-05-06
00613745003894NGSgo®-LibrX End Prep Buffer200200522026-05-06
00613745003900NGSgo®-LibrX Ligase Mix200200532026-05-06
00613745003917NGSgo®-LibrX Ligation Enhancer200200542026-05-06
00613745003924GenDx-LongMix500765212026-05-06
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)07K38-012025-12-26
00613745000091ImmunoFLOW Mycoplasma IgM Positive Control800-392539252026-04-19
00613745000145ImmunoFLOW Negative Control Mycoplasma IgM800-392139212026-04-19
00613745003863NGSgo®-AmpX v270700012026-03-30
00613745001630NGSgo Library Full Kit for Illumina IndX Plate III23423562025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IV23424562025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuite73716622025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951011193HemosIL CL Anti-Cardiolipin IgMINSTRUMENTATION LABORATORY COMPANYMID2026-04-08
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
04048474027884Cardiolipin IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027891Cardiolipin IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027907Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474035889Anti-Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
00840239035875Anti-Cardiolipin IgG/IgM ELISADRG International IncMID2023-08-25
00840239035882Anti-Cardiolipin IgA ELISADRG International IncMID2023-08-25
00840239035899Anti-Cardiolipin Screen ELISADRG International IncMID2023-08-25
00840239027887Cardiolipin IgG ELISADRG International IncMID2023-08-24
00840239027900Cardiolipin IgA ELISADRG International IncMID2023-08-24
07333066014197EliA APS Positive Control 2500/5000Phadia ABMID2020-12-09
08426951289240QUANTA Flash® aCL IgM ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289288QUANTA Flash® aCL IgA ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289295QUANTA Flash® aCL IgG ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
04048474035872Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
04048474035896Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435870Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435894Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
B24235CAAHUE010Anti-Cardiolipin-A ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MID2017-08-28
04250289503044AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503051AESKULISA® Cardiolipin-A Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503068AESKULISA® Cardiolipin-GM Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002823IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
00845714002953IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
04250289500821AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
04250289500838AESKULISA® Cardiolipin-A Aesku.Diagnostics GmbH & Co. KGMID2016-09-27