Device product
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Z-2066-2021
Product summary
- Event
- Event 88088
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only
- Official record key
device-enforcement:Z-2066-2021
Official wording
Reason: No 510(k) clearance
Code information: All lots.
Distribution pattern: 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.
Derived failure modes
-
Unknown
No 510(k) clearance