One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain immunoglobulins in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 34 | 17% |
| Bio Sb, Inc. | 34 | 17% |
| Agilent Technologies Singapore Pte Ltd | 23 | 11% |
| Cell Marque Corporation | 22 | 11% |
| Epitomics Inc. | 16 | 8% |
| Sakura Finetek U.S.A., Inc. | 12 | 6% |
| Becton, Dickinson And Company | 12 | 6% |
| Leica Biosystems Newcastle Ltd | 10 | 5% |
| Biocare Medical Llc | 9 | 4% |
| Helena Laboratories Corporation | 6 | 3% |
| Life Technologies Corporation | 6 | 3% |
| Kent Laboratories Inc | 5 | 2% |
Company = labeler of record on GUDID. 16 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 | 128 |
| MVU | Reagents, specific, analyte | 27 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 22 |
| MVU | Reagents, Specific, Analyte | 5 |
| CZN | IGA, FITC, ANTIGEN, ANTISERUM, CONTROL | 4 |
| DEO | KAPPA, FITC, ANTIGEN, ANTISERUM, CONTROL | 2 |
Use these as the dimensions to specify in a tender line.
201 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Kappa/lambda light chain immunoglobulin IVD, antibody", from 16 companies. The largest labeler is Diagnostic Biosystems, Inc. with 17% of records.
NJT (Immunohistochemistry Reagents And Kits), MVU (Reagents, specific, analyte), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), 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.