FDA.reportPublic FDA data

ImmunoDOT Thyroid Autoimmunity Panel

Primary DI
00613745058252
Brand
ImmunoDOT Thyroid Autoimmunity Panel
Company
GenBio
Model
800-5825
Catalog number
5825
Device description
The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.
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
K903843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903843000IMMUNODOT THYROID AUTOIMMUNITY PANELGeneral Biometrics, Inc.1990-10-02JNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745058252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745058252006137450582526137450582520613745058252

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal 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 both thyroglobulin and thyroid peroxidase (anti-TPO; also known as anti-microsomal antibody) 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
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
00613745002316NGSgo Library Full Kit for Illumina IndX Plate I23421562025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)93022102025-12-26
00613745002330NGSgo-MX11-373718642025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)93022202025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036132025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036232025-12-26

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
00613745030302ImmunoWELL Thyroglobulin IgG Quantitative TestGenBioJNL2016-09-24
00613745039121ImmunoDOT Thyroid Positive ControlGenBioJNL2016-09-24
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