QUANTA Lite® Gliadin IgG II ELISA Bulk Pack

Basic Information

• Brand Name: QUANTA Lite® Gliadin IgG II ELISA Bulk Pack
• Primary DI: 08426950594079
• Version / Model: 704520.10
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e127acc7-1a89-4e6c-bbd0-66f45da9c862

Device Description

1. 10x Gliadin IgG II ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgG II ELISA Low Positive 4. 5x 1.2mL prediluted Gliadin IgG II ELISA High Positive 5. 9 x50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MST	Antibodies, Gliadin	Immunology	866.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41940	Gliadin antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen.	No	Active
54947	Gliadin antibody IVD, kit, enzyme immunoassay (EIA)	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950594079	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K052142	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius