Taiwan FDA registration a55dc1033a8cca120586d5e0cec1a0ef
0.8% Affirmagen
TW: 0.8%艾芬瑪金紅血球試劑(混合細胞)
Taiwan·Risk Class 3·MD·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Oct 26, 2017 – Oct 26, 2027ActiveRegistration details
- Analysis ID
- a55dc1033a8cca120586d5e0cec1a0ef
- License Form
- Ministry of Health Medical Device Import No. 030083
- Customs Code
- DHA05603008301
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- A qualitative test to confirm the ABO blood group antibodies (A1 and B) in the blood. It needs to be used with the BioVue System.
- 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
- Oct 26, 2017
- Expiry Date
- Oct 26, 2027
About this record
Access comprehensive regulatory information for 0.8% Affirmagen in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a55dc1033a8cca120586d5e0cec1a0ef and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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