Taiwan FDA registration a398576ba036b4f1d9e97199360ad42a
“NTBIO” One Step Rapid Diagnostic Test - Ovulation LH Strip Test (Non-Sterile)
TW: "雅創” 排卵快速檢測試紙 (未滅菌)
Taiwan·Risk Class 1·MD·NTBIO DIAGNOSTICS INC.·Registered Aug 03, 2018 – Aug 03, 2023ExpiredRegistration details
- Analysis ID
- a398576ba036b4f1d9e97199360ad42a
- License Form
- Ministry of Health Medical Device Import No. 019450
- Customs Code
- DHA09401945003
Company information
- Manufacturer
- NTBIO DIAGNOSTICS INC.
- Manufacturer Country
- Canada
- Authorized Representative
- GORED ENTERPRISE CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of the "Luteinizing hormone test system (A.1485)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1485 Progesterone Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 03, 2018
- Expiry Date
- Aug 03, 2023
About this record
Access comprehensive regulatory information for “NTBIO” One Step Rapid Diagnostic Test - Ovulation LH Strip Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a398576ba036b4f1d9e97199360ad42a and manufactured by NTBIO DIAGNOSTICS INC.. The authorized representative in Taiwan is GORED ENTERPRISE CO., LTD..
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