Taiwan FDA registration 9af3784351d349dd4f1bca6c41961a1d
“Vircell” HERPES SIMPLEX 1 VIRCLIA IgG MONOTEST
TW: “凡賽爾” 第一型單純皰疹毒化學冷光免疫分析IgG試劑組
Taiwan·Risk Class 2·MD·VIRCELL, S.L·Registered Feb 13, 2019 – Feb 13, 2024ExpiredRegistration details
- Analysis ID
- 9af3784351d349dd4f1bca6c41961a1d
- License Form
- Ministry of Health Medical Device Import No. 032170
- Customs Code
- DHA05603217006
Company information
- Manufacturer
- VIRCELL, S.L
- Manufacturer Country
- Spain
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product is an indirect chemiluminescent immunoassay (CLIA) reagent with ThunderBolt Immunoassay Analyzer for the qualitative detection of anti-herpes simplex virus IgG antibodies in human serum/plasma.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3305 Herpes simplex virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 13, 2019
- Expiry Date
- Feb 13, 2024
About this record
Access comprehensive regulatory information for “Vircell” HERPES SIMPLEX 1 VIRCLIA IgG MONOTEST in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9af3784351d349dd4f1bca6c41961a1d and manufactured by VIRCELL, S.L. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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