A collection of reagents and other associated materials intended to be used alone or in combination with other IVDs for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory
| Company | Devices | Share |
|---|---|---|
| Calibrescientific Us, Inc. | 106 | 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 |
|---|---|---|
| JSK | Supplement, Culture Media | 59 |
| PPM | General Purpose Reagent | 32 |
| JCC | Ph Buffer | 12 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| JSY | Kit, Identification, Mycobacteria | 1 |
| JTS | Stains, Microbiologic | 1 |
Use these as the dimensions to specify in a tender line.
106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sputum specimen liquefaction/decontamination kit IVD", from 1 companies. The largest labeler is Calibrescientific Us, Inc. with 100% of records.
JSK (Supplement, Culture Media), PPM (General Purpose Reagent), JCC (Ph Buffer), JSM (Culture Media, Non-Propagating Transport)
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.