LJO · Class II · 21 CFR 866.3175

FDA Product Code LJO: Antigen, Iha, Cytomegalovirus

Leading manufacturers include Immucor, Inc., Diamedix Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767
Diamedix Corp.
Microbiology · 56d
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 16, 1985
CMV-IHA
K852494
Hillcrest Biologicals
Microbiology · 96d
Cleared Sep 07, 1984
CMV LATEX AGGLUTINATION TEST KIT
K841520
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 148d

About Product Code LJO - Regulatory Context