Data / Medical devices / Reagent/Device, Inoculum Calibration
Reagent/Device, Inoculum Calibration (LIE): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Reagent/Device, Inoculum Calibration (product code LIE, Class 2, 21 CFR 866.1640). 4 of them have 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, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LIE
- Device class
- 2
- Regulation
- 866.1640
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 1 |
Makers of Reagent/Device, Inoculum Calibration
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, Specification developer | 2 | June 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | West Sacramento, CA, United States | Specification developer | 1 | April 5, 2023 | 0 | 1 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 1 | June 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Remel Cleveland, A Division of Remel Inc. | Oakwood Village, OH, United States | Specification developer | 1 | June 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Plastikon Healthcare | Lawrence, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 5, 2023. 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.