A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 18 | 31% |
| Research And Diagnostic Systems, Inc. | 18 | 31% |
| Streck, Inc. | 10 | 17% |
| Siemens Healthcare Diagnostics Inc. | 5 | 8% |
| Horiba Instruments Incorporated | 2 | 3% |
| Clinical Diagnostic Solutions, Inc. | 2 | 3% |
| Becton, Dickinson And Company | 2 | 3% |
| Abbott Laboratories | 1 | 2% |
| Beckman Coulter, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 9 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 | 36 |
| JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 23 |
| JPK | Mixture, hematology quality control | 3 |
| KRY | Calibrator For Platelet Counting | 1 |
| KRX | Calibrator For Cell Indices | 1 |
Use these as the dimensions to specify in a tender line.
59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reticulocyte count IVD, control", from 9 companies. The largest labeler is Bio-Rad Laboratories, Inc. with 31% of records.
JPK (Mixture, Hematology Quality Control), JPK (MIXTURE, HEMATOLOGY QUALITY CONTROL), JPK (Mixture, hematology quality control), KRY (Calibrator For Platelet Counting)
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.