Home › Device types › QKP
Coronavirus Antigen Detection Test System.
FDA product code QKP · Class N · Unknown
140
Registered devices
26,743
Adverse events
47
Recalls
0
510(k) clearances
Devices with this code
Genabio COVID-19 Rapid Self-Test Kit — Genabio Diagnostics Inc.GenBody COVID-19 Ag Home Test — Genbody Inc.BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.QuickVue — QUIDEL CORPORATIONStatus™ COVID-19 Antigen Rapid Test for Home Use — PRINCETON BIOMEDITECH CORPORATIONBinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.BinaxNOW COVID-19 Ag Card — Alere Scarborough, Inc.BinaxNOW COVID-19 Ag Card Home Test — Alere Scarborough, Inc.Genabio COVID-19 Rapid Self-Test Kit — Genabio Diagnostics Inc.Rapid SARS-CoV-2 Antigen Test Card — LUMIQUICK DIAGNOSTICS, INC.CorDx — CORETESTS, INC.PathoCatch — MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITEDiHealth — IHEALTH LAB INC.Status™ COVID-19 Antigen Rapid Test for Home Use — PRINCETON BIOMEDITECH CORPORATIONRDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box) — WatMIND USAStatus™ COVID-19 Antigen Rapid Test for Home Use — PRINCETON BIOMEDITECH CORPORATIONBio-Self COVID-19 Antigen Home Test — BIOTEKE USA, LLCStatus™ COVID-19/Flu — PRINCETON BIOMEDITECH CORPORATIONBoson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/Kit — Xiamen Boson Biotech Co., Ltd.CorDx — CORETESTS, INC.Hotgen™ COVID-19 Antigen Home Test — Beijing Hotgen Biotech Co., Ltd.Advin COVID-19 Antigen Test @Home — ADVIN BIOTECH, INC.CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box) — WatMIND USABinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-24 | Guangzhou Pluslife Biotech Co., Ltd. | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| 2025-01-24 | Guangzhou Pluslife Biotech Co., Ltd. | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| 2023-03-31 | SD Biosensor, Inc. | The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brou |
| 2022-12-08 | Detect Headquarters | There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include dela |
| 2022-11-28 | Universal Meditech Inc. | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization. |
| 2022-09-23 | LumiraDx | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot nu |
| 2022-09-02 | LUMINOSTICS, INC dba CLIP HEALTH | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence. |
| 2022-08-09 | Jiangsu Well Biotech Co.,Ltd. | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance. |
| 2022-06-15 | North American Diagnostics | Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clear |
| 2022-04-09 | Woodside Acquisitions Inc. | Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. |
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