LGC Clinical Diagnostics, Inc.

Certificate 3832862CE01

Rev. 1Amended

Valid until: Jun 30, 2030

Certificate 3832862CE01 is a valid Quality management system issued to LGC Clinical Diagnostics, Inc. and registered in EUDAMED. Valid until June 30, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 3832862CE01
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 03443832862CE011

Validity

Issued: Nov 5, 2025
Valid from: Nov 5, 2025
Valid until: Jun 30, 2030

Manufacturer

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

VALIDATE® aHBs Test SetIVDR Class B
008500111358017M

Characteristics

Sterile: No
Human tissues: Yes
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Amended

Supersedes

3832862CE01IssuedJun 30, 2025 → Jun 30, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class B1

1 scope

DEVICE
IVDR Class B

Documents

LanguagesEN