NOVA Lite® DAPI ANA Kit

GUDID 08426950621843

1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium 5. 2x 25mL PBS II Concentrate (40x) 6 .1x Coverlips, 20 each 7. 1x 0.5mL ANA Titratable Pattern

INOVA DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: 08426950621843
• NIH Device Record Key: 4431b948-bad2-4893-8b3a-13eed0499b66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA Lite® DAPI ANA Kit
• Version Model Number: 704320
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-545-9495
• Email: support@inovadx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950621843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150155

FDA Product Code

• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-27
• Device Publish Date: 2016-08-31

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