Taiwan FDA registration 2c8d811cf512bdc83fa47212c611ce8b
"Roche" Cobaslater Type A Streptococcus Test (Unsterilized)
TW: "羅氏" 可霸斯萊特A型鏈球菌檢驗試劑 (未滅菌)
Taiwan·Risk Class 1·ROCHE MOLECULAR SYSTEMS, INC.·Registered Oct 31, 2022 – Oct 31, 2027ActiveRegistration details
- Analysis ID
- 2c8d811cf512bdc83fa47212c611ce8b
- Customs Code
- DHA09402293906
Company information
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- Classification and grading management method of medical equipment: Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3740 鏈球菌屬血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 31, 2022
- Expiry Date
- Oct 31, 2027
About this record
Access comprehensive regulatory information for "Roche" Cobaslater Type A Streptococcus Test (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2c8d811cf512bdc83fa47212c611ce8b and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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