Consulting Wallah › Device Explorer › IVD & laboratory › MUM1 transcription factor IVD, antibody
Device Explorer · FDA GUDID · GMDN 57440

MUM1 transcription factor 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 MUM1 transcription factor, also known as multiple myeloma oncogene 1 or IRF4-interferon regulator

US‑registered devices59in commercial distribution
Companies10labelers on GUDID
Single‑use22%of device records
Sterile0%labelled sterile
Prescription14%Rx‑only share
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Share of device records

Cell Marque Corporation1729%
Diagnostic Biosystems, Inc.712%
Biocare Medical Llc610%
Bio Sb, Inc.610%
Agilent Technologies Singapore Pte Ltd58%
Epitomics Inc.58%
Fuzhou Maixin Biotech Co., Ltd.47%
Leica Biosystems Newcastle Ltd47%

Top labelers

CompanyDevicesShare
Cell Marque Corporation1729%
Diagnostic Biosystems, Inc.712%
Biocare Medical Llc610%
Bio Sb, Inc.610%
Agilent Technologies Singapore Pte Ltd58%
Epitomics Inc.58%
Fuzhou Maixin Biotech Co., Ltd.47%
Leica Biosystems Newcastle Ltd47%
Biogenex Laboratories35%
Sakura Finetek U.S.A., Inc.23%

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 MUM1(MX093) AntibodyFLEX Mono Mo A-Hu MUM1 Protein Cl MUM1p RTU (DakFLEX Mono Mo A-Hu MUM1 Protein Cl MUM1p RTUFLEX Mono Mo A-Hu MUM1 Protein Cl MUM1p RTU (LiMono Mo A-Hu MUM1 Protein Cl MUM1pBONDNovocastraBOND™Novocastra™MUM-1Diagnostic BioSystemsMUM1 (EP190) Rabbit Monoclonal Primary AntibodyMUM1 (MRQ-43) Rabbit Monoclonal AntibodyMUM1 (MRQ-8) Mouse Monoclonal AntibodyANTI-MUM1/IRF4ANTI-HUMAN MUM1/IRF4

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 Kits52
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS7

GMDN & GCC registration

  • GMDN code 57440 · non‑implantable
  • Single‑use 22% · sterile 0% · Rx‑only 14% · 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) · 9

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How many mum1 transcription factor ivd, antibody products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "MUM1 transcription factor IVD, antibody", from 10 companies. The largest labeler is Cell Marque Corporation with 29% 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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