BEUDAMED
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    COVID19 TEST

    FDA Adverse Event
    Malfunction ·LUSYS LABORATORIES, INC.·Product code QKO·August 20, 2020

    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    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 Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 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 alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 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 Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKO·January 13, 2022

    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 Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 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 Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 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 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