Immucor, Inc.

Certificate HX 1804147-1

Rev. Rev. 6Supplemented

Valid until: May 10, 2028

Certificate HX 1804147-1 is a valid Quality management system issued to Immucor, Inc. and registered in EUDAMED. Valid until May 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1804147-1
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 1804147-1Rev. 6

Validity

Issued: Oct 1, 2025
Valid from: Oct 1, 2025
Valid until: May 10, 2028

Manufacturer

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
Manufacturer country: United States

Notified body

Notified body
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

History

Status changes

Supplemented

Supersedes

HX 1804147-1Quality management systemSupplementedJun 25, 2025 → May 10, 2028

Scope coverage

IVDR Class D6IVDR Class C2

8 scopes

IVR 106: Other devices intended to be used for blood grouping W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030305 - OTHER ANTIGEN TYPING REAGENTS W01030399 - IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0101: Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)] W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030301 - ABO TYPING
IVDR Class D
IVR 201: Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration W01030399 - IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS – OTHER
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0102: Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)] W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY)
IVDR Class D
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0103: Devices intended to determine markers of the Kell system Kel1 (K)] W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY)
IVDR Class D
IVR 0104: Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)] W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) W01030305 - OTHER ANTIGEN TYPING
IVDR Class D
IVR 0105: Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)] W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) W01030305 - OTHER ANTIGEN TYPING
IVDR Class D
IVR 0106: Other devices intended to be used for blood grouping W01030304 - IMMUNOHAEMATOLOGY CONTROLS W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY)
IVDR Class D

Documents

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