Taiwan FDA registration eb166323168cd9d7bb576cbd5fdb5c76
“DIESSE” CHORUS Scl-70
TW: “迪雅仕” 可錄思Scl-70抗體試劑組
Registration details
- Analysis ID
- eb166323168cd9d7bb576cbd5fdb5c76
- License Form
- Ministry of Health Medical Device Import No. 026853
- Customs Code
- DHA05602685309
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 in conjunction with the Chorus System to semi-quantitatively measure anti-Scl-70 antibodies in human serum using an 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 22, 2015
- Expiry Date
- Jan 22, 2025
About this record
Access comprehensive regulatory information for “DIESSE” CHORUS Scl-70 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number eb166323168cd9d7bb576cbd5fdb5c76 and manufactured by DIESSE DIAGNOSTICA SENESE S.P.A.. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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