FDA-Device2021-09-29Class II
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Microbiologics Inc
Hazard
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.
Affected count
218
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2021Don't want to check this manually?
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