FDA-Device2020-11-11Class II
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Primus Corporation
Hazard
The product did not receive pre-market approval or clearance.
Sold states
US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin OUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vietnam
Affected count
97 devices (USA only)
Manufactured in
4231 E 75th Ter, N/A, Kansas City, MO, United States
Products
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0321-2021Don't want to check this manually?
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