Taiwan FDA registration c681b13ced05ff6e69bd3afb957d8ad8

Lianhua Respiratory Fusion Cell Virus/Adenovirus 2-in-1 Antigen Detection Reagent

TW: 聯華呼吸道融合細胞病毒/腺病毒二合一抗原檢測試劑

Taiwan·Risk Class 1·FIRSTEP BIORESEARCH INC.·Registered Nov 01, 2024 – Nov 01, 2029Active

Registration details

Analysis ID: c681b13ced05ff6e69bd3afb957d8ad8

Company information

Manufacturer: FIRSTEP BIORESEARCH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: FIRSTEP BIORESEARCH INC.

Product details

Intended Use: It is limited to the first level of identification of "Respiratory Fusion Cell Virus Serum Reagent (C.3480)", "Adenovirus Serum Reagent (C.3020)", and "Microbial Sample Collection and Delivery Equipment (C.2900)" of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3480 呼吸道融合細胞病毒血清試劑;; C.3020 腺病毒血清試劑;; C.2900 微生物樣本收集及輸送器材
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Nov 01, 2024
Expiry Date: Nov 01, 2029

About this record

Access comprehensive regulatory information for Lianhua Respiratory Fusion Cell Virus/Adenovirus 2-in-1 Antigen Detection Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c681b13ced05ff6e69bd3afb957d8ad8 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..

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