Data / Medical devices / Gram Negative Identification Panel
Gram Negative Identification Panel (LQM): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Gram Negative Identification Panel (product code LQM, Class 1, 21 CFR 866.2660). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on April 5, 1993, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LQM
- Device class
- 1
- Regulation
- 866.2660
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| United Kingdom | 2 |
| Australia | 1 |
| Turkey | 1 |
Makers of Gram Negative Identification Panel
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Trek Diagnostic Systems, Ltd. | East Grinstead West Sussex, United Kingdom | Exporter to the US, Manufacturer | 1 | June 9, 1989 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | West Sacramento, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid Australia Pty Limited | THEBARTON South Australia, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Cleveland, A Division of Remel Inc. | Oakwood Village, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeni Biyoteknoloji Anonim Sirketi | BALCOVA Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 5, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.