A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concen
| Company | Devices | Share |
|---|---|---|
| Liofilchem Srl | 68 | 99% |
| Diamedix Corporation | 1 | 1% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 68 |
| LJO | Antigen, Iha, Cytomegalovirus | 1 |
Use these as the dimensions to specify in a tender line.
69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit", from 2 companies. The largest labeler is Liofilchem Srl with 99% of records.
JWY (Manual Antimicrobial Susceptibility Test Systems), LJO (Antigen, Iha, Cytomegalovirus)
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.