FDA-Device2016-10-26Class II
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
Sold states
Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
Affected count
US: 18,749 sales units; Foreign: 94,928 sales units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2017Don't want to check this manually?
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