Taiwan FDA registration bb580a206288ba0f7447955846f514f8
NOVA Lite DAPI ANA Kit
TW: 因諾瓦抗核抗體螢光檢驗系統
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Mar 29, 2017 – Mar 29, 2027ActiveRegistration details
- Analysis ID
- bb580a206288ba0f7447955846f514f8
- License Form
- Ministry of Health Medical Device Import No. 029523
- Customs Code
- DHA05602952303
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This group is used by indirect immunofluorescent assay (IFA) for qualitative and semi-quantitative detection of anti-nuclear antibodies (ANA) in human serological samples.
- 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
- Mar 29, 2017
- Expiry Date
- Mar 29, 2027
About this record
Access comprehensive regulatory information for NOVA Lite DAPI ANA Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bb580a206288ba0f7447955846f514f8 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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