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HSA · registration DE0509853

EUROIMMUN IIFT: Myasthenia gravis Mosaic 2

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG
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Official record identity
Registration number
DE0509853
Model name
IIFT: Myasthenia gravis Mosaic 2; IIFT: Myasthenia gravis Mosaic 2
Model identifier
FA 1435-1005-2; FA 1435-1010-2
Registration date
September 27, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
EUROIMMUN Medizinische Labordiagnostika AG
Registrant / registration holder
EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
Official description

This test kit provides qualitative or semiquantitative in vitro determination of human antibodies of immunoglobulin IgG against acetylcholine receptor and muscle-specific kinase in human serum or plasma to support the diagnosis of myasthenia gravis. This product is designed for use by medical professionals. The results should always be interpreted in connection with further laboratory methods and together with the clinical picture. The product is designed for use as IVD.

Additional source fields
Product owner address
Seekamp 31, 23560 Lübeck, Germany
Registrant address
438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.