A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue
| Company | Devices | Share |
|---|---|---|
| Leica Biosystems Richmond, Inc. | 20 | 34% |
| Simport Scientific Inc. | 13 | 22% |
| Hologic, Inc. | 7 | 12% |
| Keystone Manufacturing, Llc | 7 | 12% |
| Sansure Biotech Inc. | 5 | 9% |
| Shenzhen Dakewe Bio-Engineering Co., Ltd | 4 | 7% |
| Globe Scientific Inc. | 1 | 2% |
| Greiner Bio-One Gmbh | 1 | 2% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| IFP | Formalin, Neutral Buffered | 19 |
| JSG | Culture Media, Non-Selective And Non-Differential | 9 |
| LEA | PRESERVATIVE, CYTOLOGICAL | 6 |
| QMC | Transport Medium, Notified Per The Vtm Guidance | 4 |
| KNW | INSTRUMENT, BIOPSY | 4 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 3 |
Use these as the dimensions to specify in a tender line.
58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General tissue specimen container IVD, fixative/saline", from 8 companies. The largest labeler is Leica Biosystems Richmond, Inc. with 34% of records.
IFP (Formalin, Neutral Buffered), JSG (Culture Media, Non-Selective And Non-Differential), LEA (PRESERVATIVE, CYTOLOGICAL), QMC (Transport Medium, Notified Per The Vtm Guidance)
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.