Taiwan FDA registration 816acd3d2ebff8c18eb91604e46e8abf

Roche Kebas automatic new coronavirus nucleic acid detection reagent

TW: 羅氏可霸斯全自動新冠病毒核酸檢測試劑

Taiwan·Risk Class 3·Roche Molecular Systems, Inc.·Registered Sep 04, 2023 – Sep 04, 2028Active

Registration details

Analysis ID: 816acd3d2ebff8c18eb91604e46e8abf
Customs Code: DHA05603621802

Company information

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is used in the cobas 5800/6800/8800 system, a real-time reverse transcription polymerase chain reaction (RT-PCR) reagent designed to qualitatively detect the nucleic acid of the new coronavirus (SARS-CoV-2) in nasal, nasopharyngeal, and oropharyngeal swab swab specimens collected by healthcare professionals, who may be anyone, including those suspected of COVID-19 by healthcare professionals, asymptomatic individuals or others suspected of being related to COVID-19. The result was the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA can usually be detected in respiratory specimens during the acute phase of infection. A positive result is an indicator of the presence of SARS-CoV-2 RNA, and the clinical relevance of history and other diagnostic information needs to be assessed to determine the patient's infection status. A positive result does not rule out bacterial infection or co-infection with other viruses. A negative result does not rule out COVID-19 infection and should not be used as the sole basis for patient management decisions. Negative results must be judged in conjunction with clinical observation, medical history, and information on epidemiological pathology.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Sep 04, 2023
Expiry Date: Sep 04, 2028

About this record

Access comprehensive regulatory information for Roche Kebas automatic new coronavirus nucleic acid detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 816acd3d2ebff8c18eb91604e46e8abf and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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