A substance or reactant that produces colour in response to a biochemical reaction and intended to be used in combination with other IVDs to test a clinical specimen, typically using an enzyme immunoassay or immunoblot method. Substrate examples include NBT, B
| Company | Devices | Share |
|---|---|---|
| Bio Sb, Inc. | 93 | 57% |
| Diagnostic Biosystems, Inc. | 50 | 31% |
| Slmp, Llc | 10 | 6% |
| Hardy Diagnostics | 2 | 1% |
| Sakura Finetek U.S.A., Inc. | 2 | 1% |
| Clark Laboratories, Inc. | 1 | 1% |
| Euroimmun Medizinische Labordiagnostika Ag | 1 | 1% |
| Bio-Rad Laboratories, Inc. | 1 | 1% |
| Immco Diagnostics, Inc. | 1 | 1% |
| Diasorin Molecular Llc | 1 | 1% |
Company = labeler of record on GUDID. 10 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 | 120 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 30 |
| PPM | General Purpose Reagent | 2 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 2 |
| PPM | General purpose reagent | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
Use these as the dimensions to specify in a tender line.
162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chromogenic/colorimetric substrate reagent IVD", from 10 companies. The largest labeler is Bio Sb, Inc. with 57% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), PPM (General Purpose Reagent), JTO (Discs, Strips And Reagents, Microorganism Differentiation)
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.