A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from diffe
| Company | Devices | Share |
|---|---|---|
| Huachenyang (Shenzhen) Technology Co., Ltd | 38 | 18% |
| Medical Wire & Equipment Co.(Bath)Limited | 37 | 18% |
| Pretium Canada Packaging Ulc | 26 | 12% |
| Shenzhen Dakewe Bio-Engineering Co., Ltd | 25 | 12% |
| Bioteke Corporation (Wuxi) Co., Ltd. | 17 | 8% |
| Diagnostic Hybrids, Inc. | 16 | 8% |
| Remel, Inc. | 12 | 6% |
| Cardinal Health 200, Llc | 7 | 3% |
| Zhejiang Renon Medical Instrument Co., Ltd. | 6 | 3% |
| Aero-Med, Llc | 5 | 2% |
| Cepheid | 4 | 2% |
| Abbott Molecular Inc. | 2 | 1% |
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 |
|---|---|---|
| LIO | Device, Specimen Collection | 62 |
| JSM | Culture Media, Non-Propagating Transport | 57 |
| KXG | APPLICATOR, ABSORBENT TIPPED, STERILE | 16 |
| OIB | Blood and urine collection kit (excludes HIV testing) | 15 |
| JSG | Culture Media, Non-Selective And Non-Differential | 14 |
| JSM | CULTURE MEDIA, NON-PROPAGATING TRANSPORT | 9 |
Use these as the dimensions to specify in a tender line.
208 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General specimen collection kit IVD, clinical", from 23 companies. The largest labeler is Huachenyang (Shenzhen) Technology Co., Ltd with 18% of records.
LIO (Device, Specimen Collection), JSM (Culture Media, Non-Propagating Transport), KXG (APPLICATOR, ABSORBENT TIPPED, STERILE), OIB (Blood and urine collection kit (excludes HIV testing))
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.