FDA-Device2021-01-20Class II
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
Ortho Clinical Diagnostics Inc
Hazard
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Sold states
Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
Affected count
US= 223,788 ; OUS:=168,120 Totlal: 491,908
Manufactured in
1001 US Highway 202, N/A, Raritan, NJ, United States
Products
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2021Don't want to check this manually?
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