LIQ · Class I · 21 CFR 866.3405

FDA Product Code LIQ: Enzyme Linked Immunoabsorbent Assay, Rotavirus

Leading manufacturers include Orion Diagnostica, Inc., Meridian Diagnostics, Inc. and Biomerieux Vitek, Inc..

33
Total
33
Cleared
162d
Avg days
1984
Since
33 devices
25–33 of 33
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399
Armkel, LLC
Microbiology · 92d
Cleared Jul 18, 1985
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE
K850269
Meridian Diagnostics, Inc.
Microbiology · 176d
Cleared Oct 17, 1984
ENZYGNOST ROTAVIRUS AG
K841243
Behring Diagnostics, Inc.
Immunology · 208d
Cleared Sep 14, 1984
ROTALEX LATEX AGGLUTINATION TEST
K841319
Orion Diagnostica, Inc.
Microbiology · 165d