NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI

Basic Information

• Brand Name: NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI
• Primary DI: 08426950631019
• Version / Model: 708210
• 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: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 42cfac6c-ef23-4ee4-bb2a-193d75a36eb4
• Distribution End Date: 2024-07-31

Device Description

1. 20x 12-well bar-coded dsDNA Crithidia luciliae Substrate Slides 2. 1x 15mL FITC Anti Human IgG Conjugate with DAPI 3. 1x 0.5 mL dsDNA Positive Control 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS II Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips

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
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54901	Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay	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 a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950631019	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K880742	000

Storage Conditions

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