A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to stand
| Company | Devices | Share |
|---|---|---|
| Princeton Biomeditech Corporation | 13 | 18% |
| Quidel Corporation | 7 | 10% |
| Sekisui Diagnostics, Llc | 6 | 8% |
| Mckesson Medical-Surgical Inc. | 5 | 7% |
| Beckman Coulter, Inc. | 5 | 7% |
| E-Y Laboratories, Inc. | 3 | 4% |
| Wondfo Usa Co., Ltd. | 3 | 4% |
| Cardinal Health 200, Llc | 3 | 4% |
| Henry Schein, Inc. | 3 | 4% |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2 | 3% |
| Polymedco, Inc. | 2 | 3% |
| Easy Healthcare Corporation | 2 | 3% |
Company = labeler of record on GUDID. 23 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 |
|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | 38 |
| GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 20 |
| GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 5 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
Use these as the dimensions to specify in a tender line.
72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical", from 23 companies. The largest labeler is Princeton Biomeditech Corporation with 18% of records.
GTY (Antigens, All Groups, Streptococcus Spp.), GTY (ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.), GTZ (ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.), GTZ (Antisera, All Groups, Streptococcus Spp.)
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.