QUANTA Lite® dsDNA ELISA

Basic Information

• Brand Name: QUANTA Lite® dsDNA ELISA
• Primary DI: 08426950454502
• Version / Model: 708510
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0d90e14f-9859-44a6-8be2-96b7635f235a

Device Description

1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted dsDNA ELISA Positive 4. 1x 1.2mL prediluted dsDNA ELISA Calibrator 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 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
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46072	Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen.	No	Active
54902	Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950454502	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K903898	000

Storage Conditions

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