Taiwan FDA registration 9624deb42c8f22b751ad1f6cd37b13c5
GSP Neonatal hTSH kit
TW: 豐技新生兒促甲狀腺分析套組
Taiwan·Risk Class 2·MD·WALLAC OY·Registered Jun 26, 2019 – Jun 26, 2024ExpiredRegistration details
- Analysis ID
- 9624deb42c8f22b751ad1f6cd37b13c5
- License Form
- Ministry of Health Medical Device Import No. 032452
- Customs Code
- DHA05603245203
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- This product is used to quantitatively determine the content of human thyroid-stimulating hormone (hTSH) on dried blood spot samples in conjunction with GSP automated immunoassay equipment to screen newborns with congenital hypothyroidism.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1690 Thyroid Stimulation Hormone Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 26, 2019
- Expiry Date
- Jun 26, 2024
About this record
Access comprehensive regulatory information for GSP Neonatal hTSH kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9624deb42c8f22b751ad1f6cd37b13c5 and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..
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