MAIPA Assay

Organization name

Advanced Practical Diagnostics

SRN

BE-MF-000000572

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW041

  EUDAMED did not publish a description for this code.
• CW043

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• CW044

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• CW045

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Primary placement in France; available across 4 countries total.

Trade name

MAIPA Assay

UDI-DI code

05430000412117

Basic UDI-DI

5430000412900006Q2

Reference / catalog number

900006

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The MAIPA Assay is a qualitative in vitro diagnostic medical device intended for professional laboratory use for the detection and identification of anti-platelet antibodies in serum and plasma samples and for detecting autoantibodies bound to the platelets of the patient. The test is an aid in the diagnosis of patients with identified or suspected immunological platelet disorders like Fetal-Neonatal Allo-Immune Thrombocytopenia (FNAIT), Post-Transfusion Purpura (PTP), Platelet Refractoriness (PR) and Immune Thrombocytopenias. The MAIPA Assay is designed for manual use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W010399HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYSTOLOGY REAGENTS - OTHER

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