An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation
| Company | Devices | Share |
|---|---|---|
| Shandon Diagnostics Limited | 81 | 34% |
| Leica Biosystems Nussloch Gmbh | 40 | 17% |
| Leica Biosystems Melbourne Pty Ltd | 28 | 12% |
| Elitechgroup Inc. | 10 | 4% |
| Biomerieux Sa | 10 | 4% |
| Agilent Technologies Singapore Pte Ltd | 9 | 4% |
| Pathcom Systems Corporation | 9 | 4% |
| Biocare Medical Llc | 8 | 3% |
| Biogenex Laboratories | 7 | 3% |
| Bio Sb, Inc. | 6 | 2% |
| Rushabh Instruments, Llc | 5 | 2% |
| Ventana Medical Systems, Inc. | 4 | 2% |
Company = labeler of record on GUDID. 25 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 |
|---|---|---|
| KPA | Slide Stainer, Automated | 160 |
| KPA | Slide stainer, automated | 69 |
| KEY | Stainer, Tissue, Automated | 7 |
| KQC | Stains, Hematology | 4 |
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED | 3 |
| KPA | SLIDE STAINER, AUTOMATED | 2 |
Use these as the dimensions to specify in a tender line.
241 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microscope slide stainer IVD", from 25 companies. The largest labeler is Shandon Diagnostics Limited with 34% of records.
KPA (Slide Stainer, Automated), KPA (Slide stainer, automated), KEY (Stainer, Tissue, Automated), KQC (Stains, Hematology)
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.