Taiwan FDA registration 9151a7339e32efb82babcd43006c587c
“DIESSE” CHORUS ENA-6 S
TW: “迪雅仕” 可錄思 抗細胞核萃取物抗體試劑組
Taiwan·Risk Class 2·MD·DIESSE DIAGNOSTICA SENESE S.P.A.·Registered Jan 22, 2015 – Jan 22, 2025ExpiredRegistration details
- Analysis ID
- 9151a7339e32efb82babcd43006c587c
- License Form
- Ministry of Health Medical Device Import No. 027051
- Customs Code
- DHA05602705104
Company information
- Manufacturer
- DIESSE DIAGNOSTICA SENESE S.P.A.
- Manufacturer Country
- Italy
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- This product is used with the Chorus system to legally detect 6 cells and nuclear antigens (SS-A, SS-B, Scl-70, Sm, snRNP/Sm and Jo-1) in human serum with immunoenzymes.
- 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
- Jan 22, 2015
- Expiry Date
- Jan 22, 2025
About this record
Access comprehensive regulatory information for “DIESSE” CHORUS ENA-6 S in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9151a7339e32efb82babcd43006c587c and manufactured by DIESSE DIAGNOSTICA SENESE S.P.A.. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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