Device product
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Z-2105-2021
Product summary
- Event
- Event 88072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 kits
- Official record key
device-enforcement:Z-2105-2021
Official wording
Reason: Product distributed for use as an In-vitro Diagnostics without FDA clearance
Code information: Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023
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