Taiwan FDA registration 4d1d99251ce70507bcfe476b7c56ff2f
NovaLisa HERPES SIMPLEX VIRUS TYPE2 (HSV2) IgM
TW: 諾法鐵人類單純皰疹病毒第二型免疫球蛋白M酵素免疫分析套組
Taiwan·Risk Class 2·MD·NOVATEC IMMUNDIAGNOSTICA GMBH·Registered Sep 01, 2015 – Sep 01, 2025ExpiredRegistration details
- Analysis ID
- 4d1d99251ce70507bcfe476b7c56ff2f
- License Form
- Ministry of Health Medical Device Import No. 027564
- Customs Code
- DHA05602756407
Company information
- Manufacturer
- NOVATEC IMMUNDIAGNOSTICA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
Product details
- Intended Use
- The HSV 2 recombinant IgM enzyme-linked immunoassay test was used to detect HSV2 infection in human serum or plasma (using citric acid as an anticoagulant) in the presence of HSV1 antibodies.
- 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
- Sep 01, 2015
- Expiry Date
- Sep 01, 2025
About this record
Access comprehensive regulatory information for NovaLisa HERPES SIMPLEX VIRUS TYPE2 (HSV2) IgM in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4d1d99251ce70507bcfe476b7c56ff2f and manufactured by NOVATEC IMMUNDIAGNOSTICA GMBH. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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