Consulting Wallah › Device Explorer › IVD & laboratory › CD2 T-cell marker IVD, antibody
Device Explorer · FDA GUDID · GMDN 56924

CD2 T-cell marker 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 CD2 T-cell marker in a clinical specimen.

US‑registered devices55in commercial distribution
Companies10labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription22%Rx‑only share
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Share of device records

Cell Marque Corporation1120%
Life Technologies Corporation815%
Biogenex Laboratories611%
Bio Sb, Inc.611%
Epitomics Inc.59%
Becton, Dickinson And Company59%
Fuzhou Maixin Biotech Co., Ltd.47%
Agilent Technologies Singapore Pte Ltd47%

Top labelers

CompanyDevicesShare
Cell Marque Corporation1120%
Life Technologies Corporation815%
Biogenex Laboratories611%
Bio Sb, Inc.611%
Epitomics Inc.59%
Becton, Dickinson And Company59%
Fuzhou Maixin Biotech Co., Ltd.47%
Agilent Technologies Singapore Pte Ltd47%
Leica Biosystems Newcastle Ltd47%
Sakura Finetek U.S.A., Inc.24%

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 CD2(MX074) AntibodyMono Mo a Hu CD2/RPE, Cl MT910FLEX Mono Mo A-Hu CD2 Cl AB75 RTU (Dako Omnis)FLEX Mono Mo A-Hu CD2 Cl AB75 RTUFLEX Mono Mo A-Hu CD2 Cl AB75 RTU (Link)BOND™NovocastraNovocastra™CD2 (EP222) Rabbit Monoclonal Primary AntibodyCD2 (MRQ-11) Mouse Monoclonal AntibodyAnti-CD2ANTI-CD2Rabbit Monoclonal Anti-Human CD2 Antibody, EP222Tissue-Tek Genie®HorizonN/A

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 Kits36
MVUREAGENTS,SPECIFIC,ANALYTE8
MVUReagents, specific, analyte6
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS5

GMDN & GCC registration

  • GMDN code 56924 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 22% · OTC 7%
  • 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) · 7

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

How many cd2 t-cell marker ivd, antibody products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CD2 T-cell marker IVD, antibody", from 10 companies. The largest labeler is Cell Marque Corporation with 20% of records.

Which FDA product codes apply?

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

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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