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HSA · registration DE0509773

EUROIMMUN Calprotectin ELISA

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG
Verified
Official record identity
Registration number
DE0509773
Model name
Calprotectin ELISA
Model identifier
EQ 6831-9601 W
Registration date
September 11, 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

The enzyme immunoassay (ELISA) provides quantitative in vitro determination of calprotectin in human stool samples. 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.