Who is the manufacturer of CARDIOLIPIN IGA EIA TEST SYSTEM?

Immunoprobe, Inc. submitted the Traditional clearance for CARDIOLIPIN IGA EIA TEST SYSTEM (K952522).

What is the FDA product code for CARDIOLIPIN IGA EIA TEST SYSTEM?

MID. It is classified under 21 CFR 866.5660 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for CARDIOLIPIN IGA EIA TEST SYSTEM?

510(k) clearance (submission type: Traditional).

CARDIOLIPIN IGA EIA TEST SYSTEM

K952522 · Immunoprobe, Inc. · MID · Feb 9, 1996 · Immunology

Device Facts

Record ID	K952522
Device Name	CARDIOLIPIN IGA EIA TEST SYSTEM
Applicant	Immunoprobe, Inc.
Product Code	MID · Immunology
Decision Date	Feb 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5660
Device Class	Class 2

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).