Taiwan FDA registration d4b89f60ec1dc607691afded8bf26d5a
Beckman Coulter Access TPO Antibody Calibrators
TW: 貝克曼庫爾特亞瑟斯甲狀腺過氧化物酶抗體校正液
Taiwan·Risk Class 2·MD·IMMUNOTECH SAS, A BECKMAN COULTER COMPANY·Registered Jan 14, 2019 – Jan 14, 2024ExpiredRegistration details
- Analysis ID
- d4b89f60ec1dc607691afded8bf26d5a
- License Form
- Ministry of Health Medical Device Import No. 032036
- Customs Code
- DHA05603203602
Company information
- Manufacturer
- IMMUNOTECH SAS, A BECKMAN COULTER COMPANY
- Manufacturer Country
- France
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to correct the quantitative detection of thyroid peroxidase antibody (TPOAb) concentrations in human serum and plasma by the Access Immune Analysis System.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 14, 2019
- Expiry Date
- Jan 14, 2024
About this record
Access comprehensive regulatory information for Beckman Coulter Access TPO Antibody Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d4b89f60ec1dc607691afded8bf26d5a and manufactured by IMMUNOTECH SAS, A BECKMAN COULTER COMPANY. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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