Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042250641

FEI Number

3042250641

Entity Name

LACAR MDX TECHNOLOGIES

City/State/Country

Liege, BE

Establishment Address

Rue des Chasseurs Ardennais 10, Liege 4031, BE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

LaCAR MDx Technologies (Owner Number: 10094131)

Owner / Operator Contact Address

Rue des Chasseurs Ardennais 10, Liège, BE-WLG 4031, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SEEKER Analyte Specific Reagent SEEKER Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System	Clinical Chemistry	Class 2	862.1488	2025-11-17
PQT	Alpha-L-Iduronidase (Idua) Newborn Screening Test System	Clinical Chemistry	Class 2	862.1488	2025-11-17
PQV	ß-Glucocerebrosidase (Gba) Newborn Screening Test System	Clinical Chemistry	Class 2	862.1488	2025-11-17
PQU	Alpha-D-Glucosidase (Gaa) Newborn Screening Test System	Clinical Chemistry	Class 2	862.1488	2025-11-17
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2025-11-17
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2025-11-17

Official Correspondent

Arnaud Allaer

US Agent Details

Paul Roesch Email: paul.roesch@lacar-mdx.com Phone: (984) 2787308

Related Public Records

Same Entity

LaCAR MDx Technologies

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 3042250641. Last updated year: 2026. Please use registration number 3042250641 when referencing this establishment in official correspondence.