A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen
| Company | Devices | Share |
|---|---|---|
| Arlington Scientific, Inc. | 74 | 48% |
| Alere North America, Llc | 17 | 11% |
| Fisher Scientific Company L.L.C. | 16 | 10% |
| Becton, Dickinson And Company | 14 | 9% |
| Scimedx Corporation | 8 | 5% |
| Gold Standard Diagnostics Corporation | 6 | 4% |
| Immunostics Company, Inc | 6 | 4% |
| Sa Scientific, Ltd. | 3 | 2% |
| Stanbio Laboratory, L.P. | 2 | 1% |
| Pulse Scientific Inc | 2 | 1% |
| Teco Diagnostics | 2 | 1% |
| Diagnostic Automation, Inc. | 1 | 1% |
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 |
|---|---|---|
| GMP | Antisera, Control For Nontreponemal Tests | 68 |
| GMQ | Antigens, Nontreponemal, All | 47 |
| GMQ | ANTIGENS, NONTREPONEMAL, ALL | 19 |
| GMP | ANTISERA, CONTROL FOR NONTREPONEMAL TESTS | 18 |
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Treponema pallidum reagin antibody IVD, kit, agglutination", from 16 companies. The largest labeler is Arlington Scientific, Inc. with 48% of records.
GMP (Antisera, Control For Nontreponemal Tests), GMQ (Antigens, Nontreponemal, All), GMQ (ANTIGENS, NONTREPONEMAL, ALL), GMP (ANTISERA, CONTROL FOR NONTREPONEMAL TESTS)
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.