A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, i
| Company | Devices | Share |
|---|---|---|
| Precision Biologic Inc | 20 | 37% |
| Accriva Diagnostics Holdings, Inc. | 8 | 15% |
| Ultradent Products, Inc. | 7 | 13% |
| Tem Innovations Gmbh | 6 | 11% |
| Haemonetics Corporation | 5 | 9% |
| Patterson Dental Supply, Inc. | 2 | 4% |
| Siemens Healthcare Diagnostics Products Gmbh | 2 | 4% |
| Drew Scientific, Inc. | 1 | 2% |
| Benco Dental Supply Co. | 1 | 2% |
| Hemosonics, Llc | 1 | 2% |
| Henry Schein, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 11 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 |
|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 17 |
| MVL | CORD, RETRACTION | 8 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 7 |
| GGN | Plasma, Coagulation Control | 6 |
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 5 |
| KFF | Assay, Heparin | 5 |
Use these as the dimensions to specify in a tender line.
54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple coagulation marker IVD, reagent", from 11 companies. The largest labeler is Precision Biologic Inc with 37% of records.
GJT (Plasma, Coagulation Factor Deficient), MVL (CORD, RETRACTION), JPA (System, Multipurpose For In Vitro Coagulation Studies), GGN (Plasma, Coagulation Control)
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.