Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010099434

FEI Number

3010099434

Entity Name

KRATOS ANALYTICAL LTD.

City/State/Country

Manchester, GB

Establishment Address

Wharfside, Trafford Wharf Road, Manchester M17 1GP, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kratos Analytical Ltd. (Owner Number: 10047960)

Owner / Operator Contact Address

Wharfside, Trafford Wharf Road, Manchester, GB-MAN M17 1GP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN130013

PMA Number

N/A

All Registered Proprietary Names

VITEK MS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3361	2014-11-20

Official Correspondent

Alan Stockley

US Agent Details

Nathan Hardesty Business: Biomerieux Inc. Email: nathan.hardesty@biomerieux.com Phone: (314) 7318666

Related Public Records

Same Entity

Kratos Analytical Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010099434. Last updated year: 2026. Please use registration number 3010099434 when referencing this establishment in official correspondence.