Taiwan FDA registration b9bf7822c69be948b70cbc110b733c21
“Biohit” Gastrin-17 Advanced
TW: “百得” 胃泌素-17酵素免疫檢測試劑
Taiwan·Risk Class 2·MD·BIOHIT OYJ·Registered May 22, 2018 – May 22, 2028ActiveRegistration details
- Analysis ID
- b9bf7822c69be948b70cbc110b733c21
- License Form
- Ministry of Health Medical Device Import No. 031116
- Customs Code
- DHA05603111608
Company information
- Manufacturer
- BIOHIT OYJ
- Manufacturer Country
- Finland
- Authorized Representative
- YOULUM BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- This reagent uses enzyme-linked immunosorbent assay (ELISA) technology for the quantitative detection of G-17 (P-G-17) in human EDTA anticoagulant plasma or G-17 (S-G-17) in serum. The data of the test can be mainly used in two aspects: 1) when combined with other indicators (pepsinogen I, pepsinogen II) can assist in the diagnosis of gastric atrophic gastritis; 2) evaluate whether the gastric acid secretion is normal. This reagent is intended for in vitro diagnostic use and is not suitable for the diagnosis of gastrinomas.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1325 Gastrin Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 22, 2018
- Expiry Date
- May 22, 2028
About this record
Access comprehensive regulatory information for “Biohit” Gastrin-17 Advanced in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b9bf7822c69be948b70cbc110b733c21 and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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