11 results
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51ms
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Sources: EU EUDAMED, US FDA
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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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 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
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 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)
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022