Taiwan FDA registration f3f23b7a8cf93d8a6a8e17a7c1550a24
QUANTA Flash MPO Calibrator
TW: 因諾瓦MPO化學冷光免疫分析法校正液
Registration details
- Analysis ID
- f3f23b7a8cf93d8a6a8e17a7c1550a24
- License Form
- Ministry of Health Medical Device Import No. 027084
- Customs Code
- DHA05602708406
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- It is used for BIO-FLASH instrument calibration QUANTA Flash MPO chemical cold light immunoassay (chemiluminescent immunoassay) to measure the semi-quantitative detection of MPO immunoglobulin G antibody in human serum samples.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 03, 2015
- Expiry Date
- Mar 03, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash MPO Calibrator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f3f23b7a8cf93d8a6a8e17a7c1550a24 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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