Device product
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Z-2106-2021
Product summary
- Event
- Event 88072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2106-2021
Official wording
Reason: Product distributed for use as an In-vitro Diagnostics without FDA clearance
Code information: Lot Number: 0000101423
Distribution pattern: US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
Derived failure modes
-
Unknown
Product distributed for use as an In-vitro Diagnostics without FDA clearance