Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Lusys Laboratories, Inc. with 11 device recalls and 1 warning letter. The most recent is a warning letter dated Feb 17, 2022: Warning letter: Marketing claims, 510(k) required.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 17, 2022 | Warning letter: Marketing claims, 510(k) requiredCDRH | Warning letters |
| Jan 13, 2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)Class I · COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for mar | Device recalls |
| Jan 13, 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)Class I · COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for mar | Device recalls |
| Jan 13, 2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111Class I · COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for mar | Device recalls |
| Mar 13, 2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol paClass I · LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Eb | Device recalls |
| Mar 13, 2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohoClass I · LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Eb | Device recalls |
| Mar 13, 2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kitClass I · LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Eb | Device recalls |
| Mar 13, 2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. AlcoClass I · LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Eb | Device recalls |
| Mar 13, 2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohClass I · LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Eb | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
