Data / Medical devices / United Kingdom / Bio-Diagnostics Ltd.
Bio-Diagnostics Ltd.: FDA-registered device maker in Worcestershire, United Kingdom, 1 510(k) clearance
Bio-Diagnostics Ltd. is registered with the FDA (registration 9617136) in Worcestershire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617136
- FEI number
- 3002806511
- Address
- Upton Industrial Estate, Rectory Road, Upton-Upon Severn, Worcestershire, United Kingdom, WR8 0LX
- Owner or operator
- BIO-DIAGNOSTICS LTD. (9035474)
- Roles
- Manufacturer
- First device listed
- April 23, 2004
- Registered through
- 2026
- Brand names listed
- BIOCARDHSV-2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 1999 | K983886 | POCKIT HSV 2 RAPID TEST | LGC | Substantially Equivalent | Diagnology , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 1999. 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.