Taiwan FDA registration 556cc03772264e323019bdd0693678d2
“DIESSE” CHORUS Sm
TW: “迪雅仕” 可錄思 Sm抗核抗體試劑組
Taiwan·Risk Class 2·MD·DIESSE DIAGNOSTICA SENESE S.P.A.·Registered Jan 27, 2015 – Jan 27, 2025ExpiredRegistration details
- Analysis ID
- 556cc03772264e323019bdd0693678d2
- License Form
- Ministry of Health Medical Device Import No. 027058
- Customs Code
- DHA05602705805
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 semi-quantitatively detect anti-smith antigen (Sm) antibodies in human serum by immunoenzyme method.
- 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 27, 2015
- Expiry Date
- Jan 27, 2025
About this record
Access comprehensive regulatory information for “DIESSE” CHORUS Sm in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 556cc03772264e323019bdd0693678d2 and manufactured by DIESSE DIAGNOSTICA SENESE S.P.A.. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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