Consulting Wallah › Device Explorer › IVD & laboratory › Neurofilament protein IVD, antibody
Device Explorer · FDA GUDID · GMDN 57481

Neurofilament 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 neurofilament protein [e.g., neurofilament light protein (NF-L), neurofilament protein M (NF-M) a

US‑registered devices55in commercial distribution
Companies10labelers on GUDID
Single‑use20%of device records
Sterile0%labelled sterile
Prescription13%Rx‑only share
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Share of device records

Cell Marque Corporation1222%
Bio Sb, Inc.1222%
Diagnostic Biosystems, Inc.815%
Leica Biosystems Newcastle Ltd47%
Epitomics Inc.47%
Sakura Finetek U.S.A., Inc.47%
Agilent Technologies Singapore Pte Ltd35%
Biocare Medical Llc35%

Top labelers

CompanyDevicesShare
Cell Marque Corporation1222%
Bio Sb, Inc.1222%
Diagnostic Biosystems, Inc.815%
Leica Biosystems Newcastle Ltd47%
Epitomics Inc.47%
Sakura Finetek U.S.A., Inc.47%
Agilent Technologies Singapore Pte Ltd35%
Biocare Medical Llc35%
Biogenex Laboratories35%
Slmp, Llc24%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FLEX Mono Mo A-Hu Neurofilament Protein Cl 2F11 FLEX Mono Mo A-Hu Neurofilament Protein Cl 2F11 FLEX Mono Mo A-Hu Neurofilament Protein Cl 2F11 BONDNovocastraNovocastra™BOND™NeurofilamentDiagnostic BioSystemsNeurofilament (EP79) Rabbit Monoclonal Primary ANeurofilament (2F11) Mouse Monoclonal AntibodyNeutrophil Elastase (SP203) Rabbit Monoclonal PrIHCANTI-NEUROFILAMENTRabbit Monoclonal Anti-Human Neurofilament AntibGenemed®

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 Kits48
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS8

GMDN & GCC registration

  • GMDN code 57481 · non‑implantable
  • Single‑use 20% · sterile 0% · Rx‑only 13% · 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) · 8

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

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

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Neurofilament protein IVD, antibody", from 10 companies. The largest labeler is Cell Marque Corporation with 22% 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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