A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumera
| Company | Devices | Share |
|---|---|---|
| Bio Sb, Inc. | 127 | 64% |
| Streck, Inc. | 34 | 17% |
| Beckman Coulter, Inc. | 27 | 14% |
| Becton, Dickinson And Company | 4 | 2% |
| Beckman Coulter Ireland Inc. | 4 | 2% |
| Menarini Silicon Biosystems, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| LJG | Quality Control Slides | 63 |
| LJG | QUALITY CONTROL SLIDES | 61 |
| GGL | Control, White-Cell | 36 |
| GKZ | Counter, Differential Cell | 24 |
| JPK | Mixture, Hematology Quality Control | 4 |
| JPK | Mixture, hematology quality control | 3 |
Use these as the dimensions to specify in a tender line.
197 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple CD cell marker IVD, control", from 6 companies. The largest labeler is Bio Sb, Inc. with 64% of records.
LJG (Quality Control Slides), LJG (QUALITY CONTROL SLIDES), GGL (Control, White-Cell), GKZ (Counter, Differential Cell)
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.