
Becton Dickinson Immunocytometry Systems
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TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES is an FDA 510(k)-cleared medical device (K971205) manufactured by Becton Dickinson Immunocytometry Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 1997. Regulation: 8.