Consulting Wallah › Device Explorer › IVD & laboratory › Terminal deoxynucleotidyl transferase (TdT) IVD, a
Device Explorer · FDA GUDID · GMDN 57644

Terminal deoxynucleotidyl transferase (TdT) 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 terminal deoxynucleotidyl transferase (TdT) in a clinical specimen.

US‑registered devices75in commercial distribution
Companies14labelers on GUDID
Single‑use27%of device records
Sterile0%labelled sterile
Prescription9%Rx‑only share
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Share of device records

Bio Sb, Inc.1824%
Diagnostic Biosystems, Inc.1216%
Cell Marque Corporation1115%
Epitomics Inc.57%
Sakura Finetek U.S.A., Inc.57%
Fuzhou Maixin Biotech Co., Ltd.45%
Agilent Technologies Singapore Pte Ltd45%
Leica Biosystems Newcastle Ltd45%

Top labelers

CompanyDevicesShare
Bio Sb, Inc.1824%
Diagnostic Biosystems, Inc.1216%
Cell Marque Corporation1115%
Epitomics Inc.57%
Sakura Finetek U.S.A., Inc.57%
Fuzhou Maixin Biotech Co., Ltd.45%
Agilent Technologies Singapore Pte Ltd45%
Leica Biosystems Newcastle Ltd45%
Becton, Dickinson And Company34%
Agilent Technologies, Inc.23%
Slmp, Llc23%
Biogenex Laboratories23%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mouse Monoclonal Anti-Human TdT(MX010) AntibodyDakoMono Mo A-Hu Terminal Deoxynucleotidyl TransferaFLEX Mono Rb A-Hu Terminal Deoxynucleotidyl TNovocastraBOND™Novocastra™Tdt (P)Diagnostic BioSystemsTdT Rabbit Polyclonal AntibodyTdT (EP266) Rabbit Monoclonal Primary AntibodyIHCANTI-TDTRabbit Monoclonal Anti-Human TdT Antibody, EP266Tissue-Tek® Genie®Genemed®

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 Kits60
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS8
MVUReagents, specific, analyte8
MVUREAGENTS,SPECIFIC,ANALYTE1

GMDN & GCC registration

  • GMDN code 57644 · non‑implantable
  • Single‑use 27% · sterile 0% · Rx‑only 9% · 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) · 11

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

How many terminal deoxynucleotidyl transferase (tdt) ivd, antibody products are registered in the US?

75 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Terminal deoxynucleotidyl transferase (TdT) IVD, antibody", from 14 companies. The largest labeler is Bio Sb, Inc. with 24% of records.

Which FDA product codes apply?

NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), MVU (Reagents, specific, analyte), MVU (REAGENTS,SPECIFIC,ANALYTE)

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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