One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Ssi Diagnostica A/S | 234 | 100% |
Company = labeler of record on GUDID. 1 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 |
|---|---|---|
| GWC | ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE | 251 |
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234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Streptococcus pneumoniae culture isolate antigen IVD, antibody", from 1 companies. The largest labeler is Ssi Diagnostica A/S with 100% of records.
GWC (ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE)
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.