LJY · Class I · 21 CFR 866.3380

FDA Product Code LJY: Enzyme Linked Immunoabsorbent Assay, Mumps Virus

Leading manufacturers include Biomerieux Vitek, Inc., Zeus Scientific, Inc. and Gull Laboratories, Inc..

8
Total
8
Cleared
248d
Avg days
1983
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Mumps Virus Devices (Product Code LJY)

8 devices
1–8 of 8
Cleared Apr 23, 1998
SERAQUEST MUMPS IGG
K980059
Quest Intl., Inc.
Microbiology · 106d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857
Gull Laboratories, Inc.
Microbiology · 168d
Cleared Jul 18, 1996
MUMPS IGG TEST
K961204
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Aug 09, 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
K923903
Biomerieux Vitek, Inc.
Microbiology · 370d

About Product Code LJY - Regulatory Context