Data / Medical devices / Antiserum, Fluorescent, Chlamydia Trachomatis
Antiserum, Fluorescent, Chlamydia Trachomatis (LJP): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP, Class 1, 21 CFR 866.3120). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on September 24, 2007, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LJP
- Device class
- 1
- Regulation
- 866.3120
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 2 |
| United States | 1 |
Makers of Antiserum, Fluorescent, Chlamydia Trachomatis
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 |
|---|---|---|---|---|---|---|---|---|
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer | 2 | April 16, 1990 | 0 | 0 | 0 | api.fda.gov |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Specification developer | 1 | March 12, 1987 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | September 24, 2007 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 2007. 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.