Taiwan FDA registration 2593e7f8a21876395878f75613a54aef

ID NOW RSV

TW: 艾迪納呼吸道融合病毒核酸檢驗試劑

Taiwan·Risk Class 2·MD·Abbott Diagnostics Scarborough, Inc.·Registered Jan 22, 2018 – Jan 22, 2028Active

Registration details

Analysis ID: 2593e7f8a21876395878f75613a54aef
License Form: Ministry of Health Medical Device Import No. 030491
Customs Code: DHA05603049103

Company information

Manufacturer: Abbott Diagnostics Scarborough, Inc.
Manufacturer Country: United States
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: This product is used in conjunction with Alere i Instrument to qualitatively detect viral RNA of respiratory fusion virus (RSV) in patients with signs and symptoms of respiratory tract infection by direct nasopharyngeal swab and nasopharyngeal swab washed with viral delivery solution. This product is used in combination with clinical epidemiological risk factors to assist in the diagnosis of RSV infection in minors under 18 years of age and adults over 60 years of age.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3980 Multi-standard nucleic acid test reagent for respiratory viruses
Import Information: Imported from abroad

Dates and status

Registration Date: Jan 22, 2018
Expiry Date: Jan 22, 2028

About this record

Access comprehensive regulatory information for ID NOW RSV in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2593e7f8a21876395878f75613a54aef and manufactured by Abbott Diagnostics Scarborough, Inc.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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