FDA-Device2021-02-17Class II
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Helena Laboratories, Corp.
Hazard
Intermittent potential for shorter than expected clot times.
Sold states
Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
Affected count
205 total kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2021Don't want to check this manually?
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