LIQ · Class I · 21 CFR 866.3405

FDA Product Code LIQ: Enzyme Linked Immunoabsorbent Assay, Rotavirus

Leading manufacturers include Abbott Laboratories, Ortho Diagnostic Systems, Inc. and Behring Diagnostics, Inc..

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 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 Oct 17, 1984
ENZYGNOST ROTAVIRUS AG
K841243
Behring Diagnostics, Inc.
Immunology · 208d

About Product Code LIQ - Regulatory Context