Device product
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Z-0675-2019
Product summary
- Event
- Event 81597
- Status
- Terminated
- Classification
- Class II
- Quantity
- 992 units
- Official record key
device-enforcement:Z-0675-2019
Official wording
Reason: Unavailable
Code information: all lots
Distribution pattern: US Nationwide