Taiwan FDA registration 7fe53c1605c1d744bfb660bff4cb9cb0
recomLine HIV-1 & HIV-2 IgG
TW: 信義興人類免疫缺陷病毒抗體西方墨點試劑
Taiwan·Risk Class 3·MD·MIKROGEN GMBH·Registered Feb 16, 2017 – Feb 16, 2022ExpiredRegistration details
- Analysis ID
- 7fe53c1605c1d744bfb660bff4cb9cb0
- License Form
- Ministry of Health Medical Device Import No. 029491
- Customs Code
- DHA05602949103
Company information
- Manufacturer
- MIKROGEN GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- HEALTHYOU CO., LTD.
Product details
- Intended Use
- Western ink dot method to detect HIV-1 and HIV-2 IgG antibodies in human serum or plasma can be used as confirmation reagents for HIV-1 and HIV-2, and cannot be used as blood donor screening.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 16, 2017
- Expiry Date
- Feb 16, 2022
About this record
Access comprehensive regulatory information for recomLine HIV-1 & HIV-2 IgG in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 7fe53c1605c1d744bfb660bff4cb9cb0 and manufactured by MIKROGEN GMBH. The authorized representative in Taiwan is HEALTHYOU CO., LTD..
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