Company
LumiraDx
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2023 | LumiraDx SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area.
Catalog Number: 60566RevB Open, Classified |
KXG | None listed |
| Oct 26, 2022 | LumiraDx LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit
Catalog #: L016080109002 (EUA)
The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality
control testing performed on the Lu Terminated |
QKP | None listed |
| Jul 22, 2022 | LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Terminated |
QKO | None listed |
| Jul 22, 2022 | LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Terminated |
QKO | None listed |
| Feb 17, 2021 | LumiraDx LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048.
Part of the LumiraDx Platfo Terminated |
QKP | None listed |
| Feb 3, 2021 | LumiraDx Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from indi Terminated |
QKP | None listed |