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Manufacturers
Lusys Laboratories, Inc.
Manufacturer Address
Lusys Laboratories, Inc., 10054 Mesa Ridge Ct Ste 118-120, San Diego CA 92121-2946
Manufacturer Parent Company (2017)
Lusys Laboratories Inc
Source
USFDA
8 Events
Recall of Device Recall Ebola Virus GPVP IgS
Recall of Device Recall Ebola Virus Antigen Blood
Recall of Device Recall Ebola Virus Antigen Nasal
Recall of Device Recall Ebola Accessories assembled, selfcontained package
Recall of Device Recall Ebola GP IgM Blood (Blood Serum/Plasma/Cassette),
Recall of Device Recall Ebola VP40 IgG/IgM (Blood Serum/Plasma/Cassette),
Recall of Device Recall Ebola GP IgX Blood, Serum, Plasma, Cassette
Recall of Device Recall Ebola IgX VP40 Serum/Plasma/Blood Cassette
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8 devices in the database
Device Recall Ebola Virus GPVP IgS
Model / Serial
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product Description
Ebola Virus GP-VP IgS, Catalog No. I-124 || virus test kit
Device Recall Ebola Virus Antigen Blood
Model / Serial
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product Description
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.
Device Recall Ebola Virus Antigen Nasal
Model / Serial
Lot No. 12292014B
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product Description
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.
Device Recall Ebola Accessories assembled, selfcontained package
Model / Serial
Lot No. DEI007963
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product Description
Ebola Accessories assembled, self-contained package, Catalog No. I-104 || virus test kit
Device Recall Ebola GP IgM Blood (Blood Serum/Plasma/Cassette),
Model / Serial
Lot No. 12012014A
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product Description
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 || virus test kit
3 more
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