FDA product code QLW: Covid-19 Test Home Collection Kit Devices
QLW is the FDA product code for covid-19 test home collection kit devices. It is a Not classified device, reviewed by the Microbiology panel. Devices under QLW reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QLW devices, 1 initiated in the last five years.
Definition
Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit.
Classification
| Field | Value |
|---|---|
| Device name | Covid-19 Test Home Collection Kit Devices |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-01-24.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QLW?
QLW is the FDA product code for covid-19 test home collection kit devices. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QLW?
Not classified. Typical premarket route: PMA.
Have QLW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-01-24.
Next steps
- Run an FDA pathway report with predicate devices for product code QLW
- Run a recall and safety report across every QLW manufacturer
- Watch product code QLW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.