Consulting Wallah › Device Explorer › IVD & laboratory › Cadherin protein IVD, antibody
Device Explorer · FDA GUDID · GMDN 56860

Cadherin protein 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 a protein from the cadhrerin family [e.g., classical cadherin (E-cadherin, N-cadherin, P-cadherin

US‑registered devices113in commercial distribution
Companies12labelers on GUDID
Single‑use16%of device records
Sterile0%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Bio Sb, Inc.3027%
Cell Marque Corporation1917%
Biocare Medical Llc1816%
Sakura Finetek U.S.A., Inc.1211%
Diagnostic Biosystems, Inc.87%
Epitomics Inc.76%
Fuzhou Maixin Biotech Co., Ltd.44%
Agilent Technologies, Inc.44%

Top labelers

CompanyDevicesShare
Bio Sb, Inc.3027%
Cell Marque Corporation1917%
Biocare Medical Llc1816%
Sakura Finetek U.S.A., Inc.1211%
Diagnostic Biosystems, Inc.87%
Epitomics Inc.76%
Fuzhou Maixin Biotech Co., Ltd.44%
Agilent Technologies, Inc.44%
Leica Biosystems Newcastle Ltd44%
Biogenex Laboratories44%
Slmp, Llc22%
Ventana Medical Systems, Inc.11%

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

Brand names on the register (sample)

Mouse Monoclonal Anti-Human E-Cadherin(MX020) AnFLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU (DakoMono Mo A-Hu E-cadherin Cl NCH-38FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU (LinBONDNovocastraNovocastra™BOND™VENTANA anti-E-cadherin (36) Mouse Monoclonal PrCDH17 (M)E-cadherinE-Cadherin [CDH1/2208R]E-Cadherin (RM)Diagnostic BioSystemsDesmoglein 3 (5G11) Mouse Monoclonal Primary AntCadherin-17 (SP183) Rabbit Monoclonal Antibody

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 Kits104
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS11

GMDN & GCC registration

  • GMDN code 56860 · non‑implantable
  • Single‑use 16% · sterile 0% · Rx‑only 20% · 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

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

113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cadherin protein IVD, antibody", from 12 companies. The largest labeler is Bio Sb, Inc. with 27% of records.

Which FDA product codes apply?

NJT (Immunohistochemistry Reagents And Kits), 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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