Taiwan FDA registration 45cc888c1872babb28b21b28ab34b0de

Quickeli Solana nucleic acid detection reagent for influenza A/B virus

TW: 快得利索拉娜 A/B型流行性感冒病毒核酸檢測試劑

Taiwan·Risk Class 2·QUIDEL CORPORATION·Registered Aug 03, 2018 – Aug 03, 2028Active

Registration details

Analysis ID: 45cc888c1872babb28b21b28ab34b0de
Customs Code: DHA05603135003

Company information

Manufacturer: QUIDEL CORPORATION
Manufacturer Country: United States
Authorized Representative: BIO-CHECK LABORATORIES LTD.

Product details

Intended Use: This product is a qualitative in vitro diagnostic test that detects ribonucleic acid (RNA) of influenza virus from nasal and nasopharyngeal swabs of patients with symptoms of respiratory infection to distinguish influenza A/B virus infection.
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): C.3980 Nucleic acid test for respiratory viruses; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: Aug 03, 2018
Expiry Date: Aug 03, 2028

About this record

Access comprehensive regulatory information for Quickeli Solana nucleic acid detection reagent for influenza A/B virus in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 45cc888c1872babb28b21b28ab34b0de and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

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