Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617136

FEI Number

3002806511

Entity Name

BIO-DIAGNOSTICS LTD.

City/State/Country

WORCESTERSHIRE, GB

Establishment Address

UPTON INDUSTRIAL ESTATE,, RECTORY ROAD, UPTON-UPON SEVERN, WORCESTERSHIRE WR8 0LX, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO-DIAGNOSTICS LTD. (Owner Number: 9035474)

Owner / Operator Contact Address

UPTON INDUSTRIAL ESTATE, RECTORY ROAD, UPTON-UPON SEVERN, GB-WOR WR8 0LX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983886

PMA Number

N/A

All Registered Proprietary Names

BIOCARDHSV-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2004-04-23

Official Correspondent

Jemma Bullock

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

BIO-DIAGNOSTICS LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2242436	ZEUS SCIENTIFIC LLC	BRANCHBURG, NJ, US
2090110	CALBIOTECH, INC.	El Cajon, CA, US
1641328	ARLINGTON SCIENTIFIC, INC.	SPRINGVILLE, UT, US
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617136. Last updated year: 2026. Please use registration number 9617136 when referencing this establishment in official correspondence.