FDA-Device2021-07-21Class II
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Mercedes Medical, Inc.
Hazard
No 510(k) clearance
Sold states
Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.
Affected count
6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only
Manufactured in
12210 Rangeland Parkway, Lakewood Ranch, FL, United States
Products
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2021Don't want to check this manually?
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