Medical Device Division · registration 240341Active

Beckman Coulter, Inc.

Name: Beckman Coulter, Inc. — Medical Device Division 240341
Creator: Beckman Coulter, Inc.
Keywords: Beckman Coulter, Inc., Beckman Coulter, Inc., 240341, IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, MyoglobinIVD Class BBeckman Coulter, Inc.

Verified

Official record identity

MDACS listing number: 240341
Model name: Access Myoglobin (Reagent Pack) (973243), Access Myoglobin (Calibrators) (973244)
Registration date: August 08, 2024
Expiry date: August 07, 2029
Source update date: September 23, 2024
Status: Active

Classification

Risk class: IVD Class B
Published category: IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin

Published parties

Registrant / registration holder: Beckman Coulter Hong Kong Limited
Manufacturer: Beckman Coulter, Inc.

Official description

IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin

Additional source fields

AMD nomenclature code: 17314
Traditional Chinese local responsible person: 貝克曼庫爾特香港有限公司
Local responsible person phone: 28147431
Published manufacturer address: 250 South Kraemer Blvd., Brea, California, 92821, USA

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.