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System, Test, Infectious Mononucleosis

FDA product code KTN · Class 2 · Immunology

76
Registered devices
57
Adverse events
9
Recalls
59
510(k) clearances

Devices with this code

Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Status™ Mono card — PRINCETON BIOMEDITECH CORPORATIONMonogen 150 TESTS — BIOKIT, S.A.BioPlex 2200 — BIO-RAD LABORATORIES, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.NA — REMEL, INC.NA — REMEL, INC.ASI Color Mono II Test — ARLINGTON SCIENTIFIC, INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Detector Lex-IM — Immunostics Company, IncSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.ASI Color Mono II Test — ARLINGTON SCIENTIFIC, INC.Poly stat — POLYMEDCO, INC.NA — REMEL, INC.Detector Mono — Immunostics Company, IncDetector Color IM — Immunostics Company, IncHenry Schein — HENRY SCHEIN, INC.BioSign Mono card — PRINCETON BIOMEDITECH CORPORATIONStatus Mono Moderate Complex card — PRINCETON BIOMEDITECH CORPORATIONSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Clearview® — Alere San Diego, Inc.BioPlex 2200 — BIO-RAD LABORATORIES, INC.

Recent recalls

DateFirmReason
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2013-02-26Alere San Diego, Inc.Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
2006-02-14Remel, Inc.Some units exhibit weak false-positive reactions with some negative patient serum

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.