FDA-Device2021-12-22Class II
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Clark Laboratories, Inc.
Hazard
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Sold states
OH, UT
Affected count
53 units
Manufactured in
2823 Girts Rd, Jamestown, NY, United States
Products
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0382-2022Don't want to check this manually?
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