Medical Device Division · registration 200378Active

Beckman Coulter

Name: Beckman Coulter — Medical Device Division 200378
Creator: Beckman Coulter, Inc.
Keywords: Beckman Coulter, Beckman Coulter, 200378, IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific AntigenIVD Class CBeckman Coulter, Inc.

Verified

Official record identity

MDACS listing number: 200378
Model name: Access Hybritech p2PSA (Reagent Pack) (A49752), Access Hybritech p2PSA (Calibrators) (A49753), Access Hybritech p2PSA (QC) (A56934), Access Hybritech PSA (Reagent Pack) (37200), Access Hybritech PSA (Calibrators) (37205), Access Hybritech PSA (QC) (37209), Access Hybritech PSA (Diluent) (37206), Access Hybritech PSA (Falcon 2x100) (C22845), Access Hybritech free PSA (Reagent Pack) (37210, C22846), Access Hybritech free PSA (Calibrators) (37215), Access Hybritech free PSA (QC) (37219)
Registration date: June 13, 2025
Expiry date: November 17, 2030
Status: Active

Classification

Risk class: IVD Class C
Published category: IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

Published parties

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

Official description

IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

Additional source fields

AMD nomenclature code: 18127
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
Revision number: b

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.