NOVA Lite® Monkey Oesophagus IFA Kit

Basic Information

• Brand Name: NOVA Lite® Monkey Oesophagus IFA Kit
• Primary DI: 08426950557586
• Version / Model: 704150
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 4
• Public Version Date: 2019-01-08
• Public Version Status: Update
• Public Device Record Key: 06666992-2d6e-4cdf-98ed-f6547341ea6f

Device Description

1. 25 x Monkey Oesophagus – 10-well slide 2. 1 x 1mL Pemphigus Positive Control (prediluted) 3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted) 4. 1 x 1mL IFA System Negative Control (prediluted) 5. 1 x 15mL FITC IgG (H&L), monkey adsorbed Conjugate 6. 1 x 15mL Anti-Human IgA (α) AFF FITC 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II concentrate (x40) 9. 1 x 10mL Mounting Medium 10. 25 x Coverslips 11. 1 x 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
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55139	Skin antibody 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 skin in a clinical specimen, using a fluorescent immunoassay method. This test is typically used to aid the diagnosis of skin disorders (e.g., autoimmune bullous dermatoses such as pemphigus vulgaris, paraneoplastic pemphigus, or dermatitis herpetiformis); antibodies detected are typically directed at structural proteins of the skin and/or superficial mucosa (e.g., gliadin, desmoglein, collagen, endomysium).	No	Active
54905	Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) 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	08426950557586	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981209	000

Storage Conditions

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