FDA-Device2025-08-20Class II
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Trinity Biotech USA
Hazard
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Sold states
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Affected count
968 kits
Manufactured in
2823 Girts Rd, N/A, Jamestown, NY, United States
Products
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2025Don't want to check this manually?
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