FDA.reportPublic FDA data

ImmunoWELL Thyroglobulin IgG Quantitative Test

Primary DI
00613745030302
Brand
ImmunoWELL Thyroglobulin IgG Quantitative Test
Company
GenBio
Model
800-3030
Catalog number
3030
Device description
The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid 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
JNLImmunochemical, Thyroglobulin Autoantibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNLImmunochemical, Thyroglobulin AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905485000IMMUNOWELL THYROGLOBULIN TESTGeneral Biometrics, Inc.1991-01-25JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745030302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745030302006137450303026137450303020613745030302

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin 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 antibodies to thyroglobulin 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
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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
04048474041149Anti-Thyroid Peroxidase (Anti-TPO) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJNL2023-08-31
00840239041142Anti-Thyroid Peroxidase (Anti-TPO) ELISADRG International IncJNL2019-03-20
00816870020396Anti-TPO AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JNL2019-02-11
00816870022079Monobind AccuLite Anti-TPO CLIA Kit - 96 WellsMONOBIND, INC.JNL2019-02-11
00816879020045Autostat II Anti-Thyroid Peroxidase HYCOR BIOMEDICAL LLCJNL2016-09-26
00613745030203ImmunoWELL TPO IgG Quantitative TestGenBioJNL2016-09-24
00613745039121ImmunoDOT Thyroid Positive ControlGenBioJNL2016-09-24
00613745058252ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
00613745058894ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
07333066003993ImmunoCAP Specific IgG, Antigen tg, ThyroglobulinPhadia ABJNL2016-09-23
07333066004006ImmunoCAP Specific IgG, Antigen tg, ThyroglobulinPhadia ABJNL2016-09-23
05391516743808Trinity BiotechCLARK LABORATORIES, INC.JNL2016-09-22
15099590202910Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JNL2016-09-09