One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of anaplastic lymphoma kinase, also known as ALK protein, CD246 or p80, in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 17 | 21% |
| Bio Sb, Inc. | 12 | 15% |
| Biogenex Laboratories | 11 | 14% |
| Fuzhou Maixin Biotech Co., Ltd. | 8 | 10% |
| Agilent Technologies Singapore Pte Ltd | 6 | 8% |
| Leica Biosystems Newcastle Ltd | 5 | 6% |
| Cell Marque Corporation | 5 | 6% |
| Sakura Finetek U.S.A., Inc. | 5 | 6% |
| Ventana Medical Systems, Inc. | 4 | 5% |
| Epitomics Inc. | 4 | 5% |
| Biocare Medical Llc | 3 | 4% |
Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 68 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 10 |
| PKW | Immunohistochemistry assay, antibody, anaplastic lymphoma ki | 1 |
| MVU | Reagents, Specific, Analyte | 1 |
Use these as the dimensions to specify in a tender line.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Anaplastic lymphoma kinase IVD, antibody", from 11 companies. The largest labeler is Diagnostic Biosystems, Inc. with 21% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), PKW (Immunohistochemistry assay, antibody, anaplastic lymphoma ki), MVU (Reagents, Specific, Analyte)
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.