A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components
| Company | Devices | Share |
|---|---|---|
| Research And Diagnostic Systems, Inc. | 123 | 42% |
| Streck, Inc. | 73 | 25% |
| Bio-Rad Laboratories, Inc. | 21 | 7% |
| Sysmex Corporation | 18 | 6% |
| Siemens Healthcare Diagnostics Inc. | 14 | 5% |
| Horiba Instruments Incorporated | 10 | 3% |
| Abbott Laboratories | 8 | 3% |
| Beckman Coulter, Inc. | 8 | 3% |
| Clinical Diagnostic Solutions, Inc. | 5 | 2% |
| Horiba Abx Sas | 4 | 1% |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2 | 1% |
| Drucker Diagnostics | 2 | 1% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| JPK | Mixture, Hematology Quality Control | 218 |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 33 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 24 |
| JCN | Control, Cell Counter, Normal And Abnormal | 17 |
| JCN | CONTROL, CELL COUNTER, NORMAL AND ABNORMAL | 13 |
| GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 9 |
Use these as the dimensions to specify in a tender line.
294 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Full blood count IVD, control", from 17 companies. The largest labeler is Research And Diagnostic Systems, Inc. with 42% of records.
JPK (Mixture, Hematology Quality Control), JPK (MIXTURE, HEMATOLOGY QUALITY CONTROL), GLQ (Mixture, Control, White-Cell And Red-Cell Indices), JCN (Control, Cell Counter, Normal And Abnormal)
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.