QIAGEN GmbH

Certificate HX 1782924-1

Rev. Rev. 7Supplemented

Valid until: Jun 29, 2026

Certificate HX 1782924-1 — a Quality management system issued to QIAGEN GmbH — is approaching its expiry. Valid until June 29, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1782924-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 7
Certificate ID: 0197HX 1782924-1Rev. 7

Validity

Issued: Mar 17, 2026
Valid from: Mar 17, 2026
Valid until: Jun 29, 2026

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HX 1782924-1Quality management systemSupplementedFeb 23, 2026 → Jun 29, 2026

Scope coverage

IVDR Class C6

6 scopes

GENETIC TESTING IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Class C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050107 - Mycobacteria Genus + Species W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS W01050702 - MULTIPLE BACTERIA/FUNGI PANELS
IVDR Class C
SAMPLES COLLECTION DEVICES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W05010101 - Venous or Arterious Blood Collection Devices
IVDR Class C
NUCLEIC ACID TESTING INSTRUMENTS IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0403 Other devices intended to be used for human genetic testing W02050192 – NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents Down-classification from class D to class C of the product QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
IVDR Class C
Products of class C, companion diagnostics: GENETIC TESTING IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Class C

Documents

LanguagesEN

Scope coverage

IVDR Class C6

6 scopes

GENETIC TESTING IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Class C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050107 - Mycobacteria Genus + Species W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS W01050702 - MULTIPLE BACTERIA/FUNGI PANELS
IVDR Class C
SAMPLES COLLECTION DEVICES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W05010101 - Venous or Arterious Blood Collection Devices
IVDR Class C
NUCLEIC ACID TESTING INSTRUMENTS IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0403 Other devices intended to be used for human genetic testing W02050192 – NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents Down-classification from class D to class C of the product QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
IVDR Class C
Products of class C, companion diagnostics: GENETIC TESTING IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
IVDR Class C

Certificate HX 1782924-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HX 1782924-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer