FDA-Device2022-02-23Class I
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to
BASE 10 GENETICS INC
Hazard
The product does not have 510(k) clearance.
Sold states
US Nationwide distribution in the states of AL, CO, FL, GA, ID, IN, KY, MD, NC, NV, NY, OH, OR, TN, UT, VA, WA, and WV.
Affected count
455,791 kits
Manufactured in
70 E Lake St Ste 226, N/A, Chicago, IL, United States
Products
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2022Don't want to check this manually?
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