Taiwan FDA registration 5b9cb33b06bf03d2c719d16311a01fbe
“Immucor” Gamma ELU-KIT II
TW: “依免可” 珈瑪紅血球抗體沖出套組
Taiwan·Risk Class 2·MD·IMMUCOR, INC.·Registered Oct 16, 2017 – Oct 16, 2027ActiveRegistration details
- Analysis ID
- 5b9cb33b06bf03d2c719d16311a01fbe
- License Form
- Ministry of Health Medical Device Import No. 030074
- Customs Code
- DHA05603007400
Company information
- Manufacturer
- IMMUCOR, INC.
- Manufacturer Country
- United States
- Authorized Representative
- Y.H. BIOTEK CO., LTD.
Product details
- Intended Use
- Antibodies are obtained from intact red blood cells by rapid acid flushing.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B9175 Automated Blood Sorting and Antibody Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 16, 2017
- Expiry Date
- Oct 16, 2027
About this record
Access comprehensive regulatory information for “Immucor” Gamma ELU-KIT II in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5b9cb33b06bf03d2c719d16311a01fbe and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..
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