Taiwan FDA registration 11a14928d7e0dc2ec31fabcaa0e47146
LZI Opiates EIA Kit
TW: 靈芝鴉片酵素免疫試劑
Taiwan·Risk Class 2·MD·LIN-ZHI INTERNATIONAL, INC·Registered Nov 20, 2018 – Nov 20, 2028ActiveRegistration details
- Analysis ID
- 11a14928d7e0dc2ec31fabcaa0e47146
- License Form
- Ministry of Health Medical Device Import No. 031801
- Customs Code
- DHA05603180100
Company information
- Manufacturer
- LIN-ZHI INTERNATIONAL, INC
- Manufacturer Country
- United States
- Authorized Representative
- TAIWAN ADVANCE BIO-PHARMACEUTICAL INC.
Product details
- Intended Use
- This product is used for the qualitative or semi-quantitative determination of opium in human urine and is used with an automated biochemical analyzer with a threshold of 300 ng/mL (corrected by morphine).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A3650 Opium Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 20, 2018
- Expiry Date
- Nov 20, 2028
About this record
Access comprehensive regulatory information for LZI Opiates EIA Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 11a14928d7e0dc2ec31fabcaa0e47146 and manufactured by LIN-ZHI INTERNATIONAL, INC. The authorized representative in Taiwan is TAIWAN ADVANCE BIO-PHARMACEUTICAL INC..
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