Device product
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Z-1686-2017
Product summary
- Event
- Event 76619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,400 units
- Official record key
device-enforcement:Z-1686-2017
Official wording
Reason: After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Code information: IF0951: 10816101020055, lot numbers 29428, 31871
Distribution pattern: Product was distributed to three testing laboratories in California, New Jersey and Virginia
Derived failure modes
-
Unknown
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.