FDA-Device2021-05-05Class II
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Clark Laboratories, Inc.
Hazard
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Sold states
Worldwide distribution - US Nationwide distribution and the country of Ireland.
Affected count
80 kits
Manufactured in
2823 Girts Rd, N/A, Jamestown, NY, United States
Products
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1503-2021Don't want to check this manually?
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