Consulting Wallah › Device Explorer › IVD & laboratory › Thyroglobulin IVD, antibody
Device Explorer · FDA GUDID · GMDN 57656

Thyroglobulin IVD, antibody

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of thyroglobulin in a clinical specimen.

US‑registered devices68in commercial distribution
Companies10labelers on GUDID
Single‑use28%of device records
Sterile0%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Bio Sb, Inc.1928%
Diagnostic Biosystems, Inc.1319%
Cell Marque Corporation1116%
Agilent Technologies Singapore Pte Ltd57%
Biogenex Laboratories57%
Fuzhou Maixin Biotech Co., Ltd.46%
Epitomics Inc.46%
Biocare Medical Llc34%

Top labelers

CompanyDevicesShare
Bio Sb, Inc.1928%
Diagnostic Biosystems, Inc.1319%
Cell Marque Corporation1116%
Agilent Technologies Singapore Pte Ltd57%
Biogenex Laboratories57%
Fuzhou Maixin Biotech Co., Ltd.46%
Epitomics Inc.46%
Biocare Medical Llc34%
Slmp, Llc23%
Sakura Finetek U.S.A., Inc.23%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mouse Monoclonal Anti-Human Thyroglobulin(MX131)FLEX Poly Rb A-Hu Thyroglobulin RTU (Dako Omnis)FLEX Poly Rb A-Hu Thyroglobulin RTUFLEX Poly Rb A-Hu Thyroglobulin RTU (Link)Mono Mo A-Hu Thyroglobulin Cl DAK-Tg6Poly Rb A-Hu ThyroglobulinThyroglobulin CocktailDiagnostic BioSystemsThyroglobulin (MRQ-41) Mouse Monoclonal AntibodyThyroglobulin (2H11+6E1) Mouse Monoclonal AntiboIHCANTI-THYROGLOBULINRabbit Monoclonal Anti-Human Thyroglobulin AntibGenemed®Thyroglobulin Control SlidesThyroglobulin MMab

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NJTImmunohistochemistry Reagents And Kits61
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS9
LJGQUALITY CONTROL SLIDES1

GMDN & GCC registration

  • GMDN code 57656 · non‑implantable
  • Single‑use 28% · sterile 0% · Rx‑only 4% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 9

Use these as the dimensions to specify in a tender line.

How many thyroglobulin ivd, antibody products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Thyroglobulin IVD, antibody", from 10 companies. The largest labeler is Bio Sb, Inc. with 28% of records.

Which FDA product codes apply?

NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), LJG (QUALITY CONTROL SLIDES)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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