Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006261638

FEI Number

3006261638

Entity Name

DIAGAST

City/State/Country

LOOS Hauts-de-France, FR

Establishment Address

Parc Eurasante, 251, Avenue Eugene Avinee, LOOS Hauts-de-France 59120, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIAGAST (Owner Number: 10057342)

Owner / Operator Contact Address

Parc Eurasante, 251, Avenue Eugene Avinee, LOOS, FR-HDF 59120, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LISS - Low-Ionic-Strength Solution Neg Control PK SYSTEM CONTROL Papain Beckman Coulter Bromelin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2018-03-23
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2018-03-23
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2020-06-19
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2018-03-23

Official Correspondent

Laurent KEYSER

US Agent Details

Adrian KEENE Business: North America Science Associates, Inc Email: usagentservices@namsa.com Phone: (866) 6669455

Related Public Records

Same Entity

DIAGAST

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

View Entity Profile →

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3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006261638. Last updated year: 2026. Please use registration number 3006261638 when referencing this establishment in official correspondence.