A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CB
| Company | Devices | Share |
|---|---|---|
| Cook Incorporated | 72 | 61% |
| Research And Diagnostic Systems, Inc. | 12 | 10% |
| Sysmex Corporation | 7 | 6% |
| Siemens Healthcare Diagnostics Inc. | 5 | 4% |
| Streck, Inc. | 5 | 4% |
| Clinical Diagnostic Solutions, Inc. | 3 | 3% |
| Abbott Laboratories | 3 | 3% |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2 | 2% |
| Horiba Instruments Incorporated | 2 | 2% |
| Roche Diagnostics Gmbh | 1 | 1% |
| Horiba Abx Sas | 1 | 1% |
| Greatbatch Ltd | 1 | 1% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| DYB | INTRODUCER, CATHETER | 78 |
| KRX | Calibrator For Cell Indices | 18 |
| KRX | CALIBRATOR FOR CELL INDICES | 9 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 8 |
| KRY | Calibrator For Platelet Counting | 6 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 5 |
Use these as the dimensions to specify in a tender line.
118 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Full blood count IVD, calibrator", from 16 companies. The largest labeler is Cook Incorporated with 61% of records.
DYB (INTRODUCER, CATHETER), KRX (Calibrator For Cell Indices), KRX (CALIBRATOR FOR CELL INDICES), KRZ (Calibrator For Hemoglobin And Hematocrit Measurement)
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.