LJBClass I

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

21 CFR 866.3520 / Microbiology

LJB is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a class I device type, regulated under 21 CFR 866.3520. FDA's definition for this code reads: "The qualitative detection of measles specific IgG antibodies in serum or plasma". As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 1998-01-28, and 7 recalls.

Classification record

Product code: LJB
Device name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
FDA definition: The qualitative detection of measles specific IgG antibodies in serum or plasma.
Regulation: 21 CFR 866.3520
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 7

Clearances, product code LJB

By decision year

11 clearances under product code LJB with a decision year between 1982 and 1998, 1992 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code LJB by decision year
Year	Clearances
1982	1
1988	1
1989	1
1990	2
1991	1
1992	3
1997	1
1998	1

Applicants with the most clearances

Product code LJB

Applicants holding the most 510(k) clearances under product code LJB
Applicant	Clearances
Baxter Diagnostics, Inc.	2
Diamedix Corp.	2
Gull Laboratories, Inc.	2
Clinical Sciences, Inc.	1
Electro-Nucleonics Laboratories, Inc.	1
Inova Diagnostics, Inc.	1
M.A. Bioproducts	1
Virus Reference Laboratory, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order