Medical Device Division · registration 240424Active

Access hLH (33510), Access hLH Calibrators (33515)

Name: Access hLH (33510), Access hLH Calibrators (33515) — Medical Device Division 240424
Creator: Beckman Coulter, Inc.
Keywords: Access hLH (33510), Access hLH Calibrators (33515), Access hLH (33510), Access hLH Calibrators (33515), 240424, IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing HormoneIVD Class BBeckman Coulter, Inc.

Verified

Official record identity

MDACS listing number: 240424
Model name: Access hLH (33510), Access hLH Calibrators (33515)
Registration date: September 24, 2024
Expiry date: September 23, 2029
Source update date: November 05, 2024
Status: Active

Classification

Risk class: IVD Class B
Published category: IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone

Published parties

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

Official description

IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone

Additional source fields

AMD nomenclature code: 19117
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.