Taiwan FDA registration c73274870a10cfef4788062f468a53e5

Brahms Squamous Cell Carcinoma Antigen Test Set

TW: 布拉姆斯鱗狀上皮細胞癌抗原檢驗試劑組

Taiwan·Risk Class 2·B.R.A.H.M.S GmbH·Registered Sep 21, 2009 – Sep 21, 2029Active

Registration details

Analysis ID: c73274870a10cfef4788062f468a53e5
Customs Code: DHA00602037604

Company information

Manufacturer: B.R.A.H.M.S GmbH
Manufacturer Country: Germany
Authorized Representative: MEDTRI CO., LTD.

Product details

Intended Use: This product uses automated immunofluorescence analysis with B· R· A· H· M·S KRYPTOR、B· R· A· H· M·S KRYPTOR compact、B· R· A· H· M·S KRYPTOR compact plus and B· R· A· H· M·S KRYPTOR GOLD, USED TO DETECT SQUAMOUS CELL CARCINOMA ANTIGEN (SCCA) IN SERUM.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Import Information: import

Dates and status

Registration Date: Sep 21, 2009
Expiry Date: Sep 21, 2029

About this record

Access comprehensive regulatory information for Brahms Squamous Cell Carcinoma Antigen Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c73274870a10cfef4788062f468a53e5 and manufactured by B.R.A.H.M.S GmbH. The authorized representative in Taiwan is MEDTRI CO., LTD..

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