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 Wellcome Diagnostics.

33
Total
33
Cleared
162d
Avg days
1984
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Rotavirus Devices (Product Code LIQ)

33 devices
1–24 of 33
Cleared Aug 09, 1999
SAS ROTA TEST
K990842
Sa Scientific, Inc.
Microbiology · 147d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895
Biomerieux Vitek, Inc.
Microbiology · 59d
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585
Meridian Diagnostics, Inc.
Microbiology · 111d
Cleared Aug 08, 1997
ROTAVIRUS EIA
K964424
Trinity Biotech, Inc.
Microbiology · 276d
Cleared May 05, 1997
VIDAS ROTAVIRUS ASSAY
K965092
Biomerieux Vitek, Inc.
Microbiology · 137d
Cleared Feb 14, 1996
ROTA-DAN RAPID ROTAVIRUS EIA KIT
K951208
Eldan Technologies, Ltd.
Microbiology · 334d
Cleared Dec 14, 1994
DIARLEX ROTA-ADENO
K942286
Orion Diagnostica, Inc.
Microbiology · 236d
Cleared Feb 03, 1994
IMMUNOCARD ROTAVIRUS
K933587
Meridian Diagnostics, Inc.
Microbiology · 192d
Cleared Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
K915137
Bio-Rad Laboratories, Inc.
Microbiology · 112d
Cleared Feb 14, 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666
Dako Corp.
Microbiology · 241d
Cleared Feb 26, 1991
SLIDEX ROTA-KIT 2
K895805
Vitek Systems, Inc.
Microbiology · 516d
Cleared Jan 24, 1989
ROTACUBE
K884017
Difco Laboratories, Inc.
Microbiology · 124d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821
Abbott Laboratories
Microbiology · 66d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375
Abbott Laboratories
Microbiology · 45d
Cleared Nov 27, 1987
ROTASCREEN EIA
K873740
Mercia Diagnostics , Ltd.
Microbiology · 73d
Cleared Jan 21, 1987
WELLCOZYME ROTAVIRUS WZ01
K861628
Wellcome Diagnostics
Microbiology · 267d
Cleared Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634
Wellcome Diagnostics
Microbiology · 183d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917
Kallestad Laboratories, Inc.
Microbiology · 82d
Cleared Jul 01, 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 95d
Cleared Mar 04, 1986
ROTALEX
K860529
Orion Corp.
Microbiology · 21d
Cleared Jan 21, 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129
Orion Diagnostica, Inc.
Microbiology · 104d
Cleared Nov 26, 1985
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554
Kallestad Laboratories, Inc.
Microbiology · 92d

About Product Code LIQ - Regulatory Context