Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014684020

FEI Number

3014684020

Entity Name

BBI SOLUTIONS OEM LIMITED

City/State/Country

Crumlin Newport, GB

Establishment Address

Unit 2 Parkway, Pen-y-fan Industrial Estate, Crumlin Newport NP11 3EF, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BBI Solutions OEM Limited (Owner Number: 10058575)

Owner / Operator Contact Address

Unit 2 Parkway, Pen-y-fan Industrial Estate, Crumlin, GB-NWP NP11 3EF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2018-10-11
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2019-10-25
LQP	Campylobacter Spp.	Microbiology	Class 1	866.3110	2018-10-11
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2018-10-11

Official Correspondent

Kelly Stokes

US Agent Details

Jennifer Ackerman Business: MBS Email: jenniferackerman@bbisolutions.com Phone: (207) 7975454

Related Public Records

Same Entity

BBI Solutions OEM Limited

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

Similar Registrations

Registration Number	Establishment Name	Location
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB
3009935129	TECHLAB, INC.	Radford, VA, US
1524213	MERIDIAN BIOSCIENCE, INC.	Cincinnati, OH, US
8010383	pro-lab incorporated	Richmond Hill Ontario, CA
9610140	MERCK KGAA	DARMSTADT Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014684020. Last updated year: 2026. Please use registration number 3014684020 when referencing this establishment in official correspondence.