LogoFDA 510(k) Search
K Number
K955907
Device Name
BOEHRINGER MANNHEIM IGA ASSAY
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1996-02-09

(42 days)

Product Code
CZP
Regulation Number
866.5510
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
K040435,K982382
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).