LJB · Class I · 21 CFR 866.3520

FDA Product Code LJB: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma.

Leading manufacturers include Diamedix Corp., Gull Laboratories, Inc. and Baxter Diagnostics, Inc..

11
Total
11
Cleared
121d
Avg days
1982
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Devices (Product Code LJB)

11 devices
1–11 of 11
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552
Diamedix Corp.
Microbiology · 55d
Cleared Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620
Inova Diagnostics, Inc.
Microbiology · 82d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGG EIA
K922330
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGM EIA
K922335
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Jan 03, 1991
RUBEOLA IGM ELISA TEST
K904083
Gull Laboratories, Inc.
Microbiology · 120d
Cleared Dec 28, 1990
MEASLES IGG MICROASSAY
K903961
Diamedix Corp.
Microbiology · 122d
Cleared Dec 04, 1990
RUBEOLA IGG ELISA TEST
K904854
Gull Laboratories, Inc.
Microbiology · 36d

About Product Code LJB - Regulatory Context