Taiwan FDA registration 9eb104787409642daf6b9f60e5d80322
“Immuno Concepts” FLUORESCENT ANA TEST SYSTEM
TW: “伊目康斯特” 螢光抗核抗體檢測系統
Taiwan·Risk Class 2·MD·IMMUNO CONCEPTS NA LTD·Registered Sep 07, 2015 – Sep 07, 2025ExpiredRegistration details
- Analysis ID
- 9eb104787409642daf6b9f60e5d80322
- License Form
- Ministry of Health Medical Device Import No. 027672
- Customs Code
- DHA05602767200
Company information
- Manufacturer
- IMMUNO CONCEPTS NA LTD
- Manufacturer Country
- United States
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
Product details
- Intended Use
- Indirect immunofluorescent antibody detection was used to semi-quantitatively detect antinuclear antibodies in human serum.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5100 Antinuclear antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 07, 2015
- Expiry Date
- Sep 07, 2025
About this record
Access comprehensive regulatory information for “Immuno Concepts” FLUORESCENT ANA TEST SYSTEM in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9eb104787409642daf6b9f60e5d80322 and manufactured by IMMUNO CONCEPTS NA LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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