ImmuView COVID-19 Antigen Home Test
CTK BIOTECH INC. · Model R0182CHT-2T · UDI-DI 00855402007955
Description
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
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 brought close to the nos |
| 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 delay or lack of support |
| 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 numbers for SARS-CoV-2 |
| 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, clearance, or authorizati |
| 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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