NOVA Lite® ANCA Formalin Kit

Basic Information

• Brand Name: NOVA Lite® ANCA Formalin Kit
• Primary DI: 08426950594109
• Version / Model: 708297
• 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: 6ad0b127-37bf-40e1-bf67-d38e04adc085

Device Description

1. 20x12-well ANCA Neutrophil substrate slides (formalin-fixed) 2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL cANCA Positive Control (prediluted) 4. 1x 1mL ANA Positive Control (prediluted) 5. 1x 1mL IFA System Negative Control 6. 1x 15mL anti Human IgG AFF Fluorescein with Evans Blue 7. 2x 25mL PBS II Concentrate (40x) 8. 1x 3mL 1% Evans Blue 9. 1x 10mL Mounting Medium 10. 1x 20 Coverslips 11. 1x Instruction leaflet

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
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55061	Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) 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	08426950594109	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K965133	000

Storage Conditions

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