Consulting Wallah › Device Explorer › IVD & laboratory › c-MYC proto-oncogene protein IVD, antibody
Device Explorer · FDA GUDID · GMDN 63906

c-MYC proto-oncogene 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 c-MYC proto-oncogene protein, also referred to as MYC, in a clinical specimen.

US‑registered devices50in commercial distribution
Companies7labelers on GUDID
Single‑use16%of device records
Sterile0%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Bio Sb, Inc.1836%
Biogenex Laboratories714%
Diagnostic Biosystems, Inc.714%
Biocare Medical Llc612%
Cell Marque Corporation510%
Epitomics Inc.510%
Sakura Finetek U.S.A., Inc.24%

Top labelers

CompanyDevicesShare
Bio Sb, Inc.1836%
Biogenex Laboratories714%
Diagnostic Biosystems, Inc.714%
Biocare Medical Llc612%
Cell Marque Corporation510%
Epitomics Inc.510%
Sakura Finetek U.S.A., Inc.24%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Anti-C-myc-Proteinc-MycDiagnostic BioSystemsc-Myc (EP121) Rabbit Monoclonal Primary AntibodyAnti- c-MycRabbit Monoclonal Anti-Human c-Myc Antibody, EP1Tissue-Tek Genie®c-Myc MMabTinto c-Myc, MMabTinto c-Myc MMabc-Myc RMabTinto c-Myc RMabTinto c-Myc ,RMabTinto c-Myc (RBT-CMYC)c-Myc (RBT-CMYC)

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 Kits42
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS8

GMDN & GCC registration

  • GMDN code 63906 · non‑implantable
  • Single‑use 16% · sterile 0% · Rx‑only 10% · OTC 8%
  • 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) · 12

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

How many c-myc proto-oncogene protein ivd, antibody products are registered in the US?

50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "c-MYC proto-oncogene protein IVD, antibody", from 7 companies. The largest labeler is Bio Sb, Inc. with 36% 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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