Taiwan FDA registration 5e0549c5e21bac509c8f434821edf547
“DAKO” PD-L1 IHC 22C3 pharmDx
TW: “達克” PD-L1免疫組織化學染色22C3檢測套組
Taiwan·Risk Class 3·MD·Agilent Technologies, Inc.·Registered Nov 24, 2016 – Nov 24, 2026ActiveRegistration details
- Analysis ID
- 5e0549c5e21bac509c8f434821edf547
- License Form
- Ministry of Health Medical Device Import No. 028961
- Customs Code
- DHA05602896109
Company information
- Manufacturer
- Agilent Technologies, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- SCN TRADING COMPANY LIMITED
Product details
- Intended Use
- Efficacy changed to (cancellation of tumor indication - uroepithelial carcinoma): detailed as approved Chinese instructions.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B1860 Immunopathological histochemical reagents and kits
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 24, 2016
- Expiry Date
- Nov 24, 2026
About this record
Access comprehensive regulatory information for “DAKO” PD-L1 IHC 22C3 pharmDx in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5e0549c5e21bac509c8f434821edf547 and manufactured by Agilent Technologies, Inc.. The authorized representative in Taiwan is SCN TRADING COMPANY LIMITED.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices