Consulting Wallah › Device Explorer › IVD & laboratory › CD14 cell marker IVD, antibody
Device Explorer · FDA GUDID · GMDN 56946

CD14 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 CD14 cell marker in a clinical specimen.

US‑registered devices57in commercial distribution
Companies8labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Life Technologies Corporation1628%
Becton, Dickinson And Company1221%
Bio Sb, Inc.1221%
Cell Marque Corporation611%
Epitomics Inc.59%
Agilent Technologies Singapore Pte Ltd35%
Sakura Finetek U.S.A., Inc.24%
Biogenex Laboratories12%

Top labelers

CompanyDevicesShare
Life Technologies Corporation1628%
Becton, Dickinson And Company1221%
Bio Sb, Inc.1221%
Cell Marque Corporation611%
Epitomics Inc.59%
Agilent Technologies Singapore Pte Ltd35%
Sakura Finetek U.S.A., Inc.24%
Biogenex Laboratories12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mono Mo a Hu CD14/RPE, Cl TÜK4Mono Mo A-Hu CD14/FITC Cl TÜK4Mono Mo A-Hu CD14 Cl TÜK4CD14 (EPR3653) Rabbit Monoclonal Primary AntibodCD14 (EPR3653) Rabbit Monoclonal AntibodyANTI-CD14Rabbit Monoclonal Anti-Human CD14 Antibody, EP12Tissue-Tek Genie®HorizonN/ACD14 RMabTinto CD14 RMabTinto CD14, RMabTinto CD14 ,RMabCD14 MMabTinto CD14 MMab

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MVUReagents, specific, analyte30
NJTImmunohistochemistry Reagents And Kits24
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS3

GMDN & GCC registration

  • GMDN code 56946 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 30% · 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) · 7

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How many cd14 cell marker ivd, antibody products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CD14 cell marker IVD, antibody", from 8 companies. The largest labeler is Life Technologies Corporation with 28% of records.

Which FDA product codes apply?

MVU (Reagents, specific, analyte), 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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