Product Code: LJY FDA class 1 21 CFR 866.3380

Enzyme Linked Immunoabsorbent Assay, Mumps Virus

Microbiology

Enzyme Linked Immunosorbent Assay (ELISA), Mumps Virus is a serological diagnostic test used to detect antibodies against the mumps virus, supporting diagnosis of mumps infection or assessment of immune status. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is LJY, regulated under 21 CFR 866.3380, within the Microbiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LJY in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LJY
Device Class: FDA class 1
Regulation Number: 866.3380
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K991274	MUMPS IGG ELISA TEST SYSTEM	Sep 03, 1999	Substantially Equivalent	Columbia Bioscience, Inc.
K980059	SERAQUEST MUMPS IGG	Apr 23, 1998	Substantially Equivalent	Quest Intl., Inc.
K971857	MUMPS IGG ELISA TESTY	Nov 04, 1997	Substantially Equivalent	Gull Laboratories, Inc.
K961204	MUMPS IGG TEST	Jul 18, 1996	Substantially Equivalent	Zeus Scientific, Inc.
K925209	MUMPS STAT	Oct 14, 1994	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K923903	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA	Aug 09, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K897006	PHARMACIA MUMPS IGG ELISA	Jul 26, 1990	Substantially Equivalent	Pharmacia Eni Diagnostics, Inc.
K830045	MUMPSELISA TEST KIT	May 13, 1983	Substantially Equivalent	M.A. Bioproducts