A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Bio Sb, Inc. | 51 | 96% |
| Siemens Healthcare Diagnostics Inc. | 2 | 4% |
Company = labeler of record on GUDID. 2 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 | 34 |
| LJG | QUALITY CONTROL SLIDES | 17 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 2 |
Use these as the dimensions to specify in a tender line.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cytokeratin IVD, control", from 2 companies. The largest labeler is Bio Sb, Inc. with 96% of records.
LJG (Quality Control Slides), LJG (QUALITY CONTROL SLIDES), JJX (Single (specified) analyte controls (assayed and unassayed))
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.