Device product
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
Z-0674-2019
Product summary
- Event
- Event 81597
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26745 units
- Official record key
device-enforcement:Z-0674-2019
Official wording
Reason: Unavailable
Code information: all lots
Distribution pattern: US Nationwide