Taiwan FDA registration 854bcdf1344619e821c853d71d982147
AutoDELFIA Neonatal 17α-OH-progesterone kit
TW: 豐技歐圖岱奧菲新生兒17-黃體酯酮試驗套組
Taiwan·Risk Class 2·MD·WALLAC OY·Registered Mar 24, 2017 – Mar 24, 2022ExpiredRegistration details
- Analysis ID
- 854bcdf1344619e821c853d71d982147
- License Form
- Ministry of Health Medical Device Import No. 029520
- Customs Code
- DHA05602952000
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- This kit was used to quantify human 17α-progesterone (17-OHP) content in neonatal screening filter blood films, using an automated analysis of the 1235 Outudelfi Immunoassay to screen for neonatal congenital adrenal hyperplasia (CAH).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1395 17-Progesterone Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 24, 2017
- Expiry Date
- Mar 24, 2022
About this record
Access comprehensive regulatory information for AutoDELFIA Neonatal 17α-OH-progesterone kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 854bcdf1344619e821c853d71d982147 and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..
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