Taiwan FDA registration 6b5f6a31166f2fdc3c1334cac342788b
AESKUSLIDES nDNA (Crithidia luciliae)
TW: 愛視酷抗nDNA抗體螢光檢驗系統
Taiwan·Risk Class 2·MD·AESKU.DIAGNOSTICS GMBH & CO. KG·Registered Jun 27, 2019 – Jun 27, 2024ExpiredRegistration details
- Analysis ID
- 6b5f6a31166f2fdc3c1334cac342788b
- License Form
- Ministry of Health Medical Device Import No. 032455
- Customs Code
- DHA05603245509
Company information
- Manufacturer
- AESKU.DIAGNOSTICS GMBH & CO. KG
- Manufacturer Country
- Germany
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product uses indirect immunofluorescence analysis to detect native double-stranded DNA IgG 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
- Jun 27, 2019
- Expiry Date
- Jun 27, 2024
About this record
Access comprehensive regulatory information for AESKUSLIDES nDNA (Crithidia luciliae) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6b5f6a31166f2fdc3c1334cac342788b and manufactured by AESKU.DIAGNOSTICS GMBH & CO. KG. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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