Coronavirus Disease 2019 Real Time PCR Kit
Basic Information
- Primary DI
- 06936595751765
- Basic UDI-DI Code
- B-06936595751765
- Reference
- PCR5101Y1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
Additional Description
The Coronavirus Disease 2019 RT-PCR Kit is a reagent system, based on the real-time reverse transcription polymerase chain reaction (qRT-PCR) technology, for the in vitro qualitative detection of SARS-CoV-2 specific RNA in human nasopharyngeal swabs (NPS) and sputum. The primer and probe sets are designed for specific detection of SARS-CoV-2 (ORF1ab and N gene). This test is intended for use as an aid in the diagnosis of COVID-19 caused by infection of SARS-CoV-2 in the humans. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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