Taiwan FDA registration 97d5f667e3b998e52f03037f0c2f32b8

Quidel Solana HSV 1+2/VZV assay

TW: “快得利” 索拉娜第1/2型單純皰疹/帶狀皰疹病毒核酸檢測試劑

Taiwan·Risk Class 2·MD·QUIDEL CORPORATION·Registered Mar 09, 2018 – Mar 09, 2023Expired

Registration details

Analysis ID: 97d5f667e3b998e52f03037f0c2f32b8
License Form: Ministry of Health Medical Device Import No. 030519
Customs Code: DHA05603051902

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 detection reagent using constant temperature amplification technology to isolate and purify the DNA of herpes simplex virus type 1/2/2 / herpes zoster virus from skin or mucosal lesions of suspected infected patients for qualitative and typing detection.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3305 Herpes simplex virus serum reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 09, 2018
Expiry Date: Mar 09, 2023

About this record

Access comprehensive regulatory information for Quidel Solana HSV 1+2/VZV assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 97d5f667e3b998e52f03037f0c2f32b8 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

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