One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 18 | 31% |
| Bio Sb, Inc. | 17 | 29% |
| Agilent Technologies Singapore Pte Ltd | 8 | 14% |
| Kent Laboratories Inc | 6 | 10% |
| Leica Biosystems Newcastle Ltd | 4 | 7% |
| Slmp, Llc | 4 | 7% |
| Randox Laboratories Limited | 2 | 3% |
Company = labeler of record on GUDID. 7 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 | 43 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 3 |
| MVU | Reagents, specific, analyte | 2 |
| DFT | Igm, Antigen, Antiserum, Control | 2 |
| CGM | Method, Immunodiffusion, Immunoglobulins (G, A, M) | 2 |
| DEY | IGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL | 1 |
Use these as the dimensions to specify in a tender line.
59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total immunoglobulin M (IgM total) IVD, antibody", from 7 companies. The largest labeler is Diagnostic Biosystems, Inc. with 31% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), MVU (Reagents, specific, analyte), DFT (Igm, Antigen, Antiserum, Control)
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.
Add total immunoglobulin m (igm total) ivd, antibody to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.