LJO · Class II · 21 CFR 866.3175

FDA Product Code LJO: Antigen, Iha, Cytomegalovirus

Leading manufacturers include Immucor, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and E.I. Dupont DE Nemours & Co., Inc..

12
Total
12
Cleared
162d
Avg days
1983
Since

FDA 510(k) Cleared Antigen, Iha, Cytomegalovirus Devices (Product Code LJO)

12 devices
1–12 of 12
Cleared Mar 22, 2021
Capture-CMV
K203612
Immucor, Inc.
Microbiology · 102d
Cleared Feb 04, 2019
Capture-CMV
K183571
Immucor, Inc.
Microbiology · 45d
Cleared May 01, 1998
CMVGEN
K974456
Instrumentation Laboratory CO
Microbiology · 157d
Cleared Jul 24, 1996
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 460d
Cleared Sep 07, 1984
CMV LATEX AGGLUTINATION TEST KIT
K841520
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 148d

About Product Code LJO - Regulatory Context