Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Hochuen Medical Technology Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
How Is QLT Classified?
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices is FDA product code QLT, not classified.
How Does It Reach the US Market?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.
What Do the Recalls Say?
The FDA has recorded 11 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Device Design (4), Process control (3) and Material/Component Contamination (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.