The DRG Gliadin IgA ELISA test system is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease.

The DRG Gliadin IgA ELISA test system is intended for the qualitative and semi
Gliadin IgA ELISA - EIA-3370

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is intended to be used as an aid in the diagnosis of Coeliac disease.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MST

Device Name: Antibodies, Gliadin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5750

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00840239033703

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A