FDA-Device2024-06-12Class II
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Becton Dickinson & Co.
Hazard
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Sold states
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Affected count
2,061 kits
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2023-2024Don't want to check this manually?
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