Taiwan FDA registration 7fb45623037f20e3ad0b4ca8f7e2efdb
Beckman Coulter Access Intact PTH Calibrators
TW: 貝克曼庫爾特亞瑟斯完整副甲狀腺激素校正液
Taiwan·Risk Class 2·MD·IMMUNOTECH SAS, A BECKMAN COULTER COMPANY·Registered Dec 03, 2018 – Dec 03, 2023ExpiredRegistration details
- Analysis ID
- 7fb45623037f20e3ad0b4ca8f7e2efdb
- License Form
- Ministry of Health Medical Device Import No. 031952
- Customs Code
- DHA05603195205
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 Access Intact PTH assay, which uses the Access Immunoassay System to quantitatively detect the concentration of parathyrin (PTH) in human serum and plasma.
- 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
- Dec 03, 2018
- Expiry Date
- Dec 03, 2023
About this record
Access comprehensive regulatory information for Beckman Coulter Access Intact PTH Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7fb45623037f20e3ad0b4ca8f7e2efdb 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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