Lusys Laboratories, Inc.
San Diego, CA, US
Lusys Laboratories, Inc. appears in FDA device records in San Diego, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 11
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0718-2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. | Class I | Open, Classified | |
| Z-0717-2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test) | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. | Class I | Open, Classified | |
| Z-0716-2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. | Class I | Open, Classified | |
| Z-1335-2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1334-2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test. | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1333-2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test. | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1332-2015 | Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1331-2015 | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1330-2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1329-2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests. | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated | |
| Z-1328-2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml) | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain