An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., perform
| Company | Devices | Share |
|---|---|---|
| Instrumentation Laboratory Company | 29 | 37% |
| Sysmex Corporation | 12 | 15% |
| Helena Laboratories Corporation | 11 | 14% |
| Diagnostica Stago | 10 | 13% |
| Haemonetics Corporation | 5 | 6% |
| Hemosonics, Llc | 4 | 5% |
| Siemens Healthcare Diagnostics Products Gmbh | 3 | 4% |
| Tcoag Ireland Limited | 2 | 3% |
| Tem Innovations Gmbh | 1 | 1% |
| Accriva Diagnostics Holdings, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 29 |
| GKP | INSTRUMENT, COAGULATION, AUTOMATED | 24 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 10 |
| JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | 8 |
| GKP | Instrument, Coagulation, Automated | 5 |
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coagulation analyser IVD, laboratory", from 10 companies. The largest labeler is Instrumentation Laboratory Company with 37% of records.
JPA (SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES), GKP (INSTRUMENT, COAGULATION, AUTOMATED), JPA (System, Multipurpose For In Vitro Coagulation Studies), JBP (ACTIVATED WHOLE BLOOD CLOTTING TIME)
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.