A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Hybrids, Inc. | 398 | 99% |
| Grainger International, Inc. | 3 | 1% |
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 |
|---|---|---|
| KIR | CELLS, ANIMAL AND HUMAN, CULTURED | 383 |
| GQN | Antigen, cf (including cf control), herpesvirus hominis 1,2 | 15 |
| GQL | Antisera, fluorescent, herpesvirus hominis 1,2 | 15 |
| KIZ | Dish, Tissue Culture | 3 |
Use these as the dimensions to specify in a tender line.
401 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cell culture line IVD", from 2 companies. The largest labeler is Diagnostic Hybrids, Inc. with 99% of records.
KIR (CELLS, ANIMAL AND HUMAN, CULTURED), GQN (Antigen, cf (including cf control), herpesvirus hominis 1,2), GQL (Antisera, fluorescent, herpesvirus hominis 1,2), KIZ (Dish, Tissue Culture)
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.