Company
Lusys Laboratories, Inc.
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)
11recalls (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) |
|---|---|---|---|
| Jan 13, 2022 | Lusys Laboratories, Inc. COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 Open, Classified |
QKO | None listed |
| Jan 13, 2022 | Lusys Laboratories, Inc. Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test) Open, Classified |
QKP | None listed |
| Jan 13, 2022 | Lusys Laboratories, Inc. LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) Open, Classified |
QKP | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. Ebola Virus GP-VP IgS, Catalog No. I-124
virus test kit Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. 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 Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. 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 Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. Ebola Accessories assembled, self-contained package, Catalog No. I-104
virus test kit Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103
virus test kit Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. 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 via Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. 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 (0.5 Terminated |
N/A | None listed |
| Apr 9, 2015 | Lusys Laboratories, Inc. 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) Terminated |
N/A | None listed |