LJZClass I

Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

21 CFR 866.3375 / Microbiology

LJZ is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a class I device type, regulated under 21 CFR 866.3375. As of 2026-09-10, FDA records hold 13 510(k) clearances under this code, the most recent dated 1999-01-11, and 4 recalls.

Classification record

Product code: LJZ
Device name: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Regulation: 21 CFR 866.3375
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: 13
Ingested recalls: 4

Clearances, product code LJZ

By decision year

13 clearances under product code LJZ with a decision year between 1983 and 1999, 1997 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code LJZ by decision year
Year	Clearances
1983	1
1989	2
1991	1
1992	2
1994	1
1997	5
1999	1

Applicants with the most clearances

Product code LJZ

Applicants holding the most 510(k) clearances under product code LJZ
Applicant	Clearances
Zeus Scientific LLC	3
Diatech Diagnostica, Ltd.	2
Genbio	2
Medical Diagnostic Technologies, Inc.	2
Immunoprobe, Inc.	1
M.A. Bioproducts	1
Meridian Diagnostics, Inc.	1
Shared Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order