QUANTA Lite® RNA Pol III ELISA

Basic Information

• Brand Name: QUANTA Lite® RNA Pol III ELISA
• Primary DI: 08426950506362
• Version / Model: 704555
• 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: 55f64029-c462-4b2d-94f3-a739a7bfcb4b

Device Description

1. 1x RNA Pol III ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted, ready to use, ELISA Negative Control 3. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA Low Positive 4. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA High Positive 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
NYO	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61259	RNA polymerase III antibody (anti-Pol III) 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-RNA polymerase III antibodies (anti-Pol III) 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	08426950506362	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070066	000

Storage Conditions

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