FDA-Device2016-03-30Class II
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Qiagen Sciences LLC
Hazard
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
Sold states
Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
Affected count
The total amount of product distributed 152,900 Tubes
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1230-2016Don't want to check this manually?
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