Taiwan FDA registration dbba860c9323a5f1cc963c3249b1b307
“Ortho” DAT/IDAT cassette
TW: “奧索” 拜而優系統(直接抗球蛋白試驗/間接抗球蛋白試驗卡片)
Taiwan·Risk Class 2·MD·ORTHO-CLINICAL DIAGNOSTICS·Registered Sep 21, 2015 – Sep 21, 2025ExpiredRegistration details
- Analysis ID
- dbba860c9323a5f1cc963c3249b1b307
- License Form
- Ministry of Health Medical Device Import No. 027688
- Customs Code
- DHA05602768802
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- Qualitative detection of immunoglobulins or complement bound to red blood cells (anti-IgG and anti-C3b, anti-C3d).
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B9175 Automated Blood Sorting and Antibody Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 21, 2015
- Expiry Date
- Sep 21, 2025
About this record
Access comprehensive regulatory information for “Ortho” DAT/IDAT cassette in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dbba860c9323a5f1cc963c3249b1b307 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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