Taiwan FDA registration e970a514d4469c93c2e18192a35be8e8
QUANTA Flash ENA7 Reagents
TW: 因諾瓦7項抗核抗體化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA Diagnostics, Inc·Registered Jul 12, 2019 – Jul 12, 2024ExpiredRegistration details
- Analysis ID
- e970a514d4469c93c2e18192a35be8e8
- License Form
- Ministry of Health Medical Device Import No. 032465
- Customs Code
- DHA05603246502
Company information
- Manufacturer
- INOVA Diagnostics, Inc
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product is equipped with Bio-Flash instrument to qualitatively monitor IgG antibodies against Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum by chemical cold light immunoassay.
- 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
- Jul 12, 2019
- Expiry Date
- Jul 12, 2024
About this record
Access comprehensive regulatory information for QUANTA Flash ENA7 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e970a514d4469c93c2e18192a35be8e8 and manufactured by INOVA Diagnostics, Inc. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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