FDA-Device2021-07-21Class II
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
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
SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs
Manufactured in
12210 Rangeland Parkway, Lakewood Ranch, FL, United States
Products
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2021Don't want to check this manually?
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