Consulting Wallah › Device Explorer › IVD & laboratory › Homeobox protein CDX-2 IVD, antibody
Device Explorer · FDA GUDID · GMDN 57333

Homeobox protein CDX-2 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 homeobox protein CDX-2, also referred to as caudal-type homeobox protein 2, in a clinical specime

US‑registered devices78in commercial distribution
Companies11labelers on GUDID
Single‑use26%of device records
Sterile0%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Biocare Medical Llc1924%
Bio Sb, Inc.1215%
Diagnostic Biosystems, Inc.1114%
Cell Marque Corporation79%
Epitomics Inc.68%
Biogenex Laboratories56%
Fuzhou Maixin Biotech Co., Ltd.45%
Agilent Technologies, Inc.45%

Top labelers

CompanyDevicesShare
Biocare Medical Llc1924%
Bio Sb, Inc.1215%
Diagnostic Biosystems, Inc.1114%
Cell Marque Corporation79%
Epitomics Inc.68%
Biogenex Laboratories56%
Fuzhou Maixin Biotech Co., Ltd.45%
Agilent Technologies, Inc.45%
Slmp, Llc45%
Sakura Finetek U.S.A., Inc.45%
Leica Biosystems Newcastle Ltd23%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rabbit Monoclonal Anti-Human CDX2(MXR024) AntiboFLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU (Dako OmnMono Mo A-Hu CDX2 Cl DAK-CDX2FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU (Link)BONDBOND™CDX2 (RM)CDX2CDX2 [BC39]Diagnostic BioSystemsCDX-2 (EPR2764Y) Rabbit Monoclonal Primary AntibCDX-2 (EPR2764Y) Rabbit Monoclonal AntibodyIHCANTI-CDX-2ANTI- CDX-2ANTI-CDX2

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 Kits63
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS15
MYAImmunohistochemistry Antibody Assay, Estrogen Receptor1

GMDN & GCC registration

  • GMDN code 57333 · non‑implantable
  • Single‑use 26% · sterile 0% · Rx‑only 27% · 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) · 17

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How many homeobox protein cdx-2 ivd, antibody products are registered in the US?

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Homeobox protein CDX-2 IVD, antibody", from 11 companies. The largest labeler is Biocare Medical Llc with 24% of records.

Which FDA product codes apply?

NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor)

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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