FDA-Device2020-09-23Class III
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
Oxford Immunotec
Hazard
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Affected count
583 units
Manufactured in
94C Innovation Drive, Milton Park, Abingdon, N/A, United Kingdom
Products
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2020Don't want to check this manually?
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