NOVA Lite® ANA KSL Kit

GUDID 08426950514008

1. 25x 8-well ANA KSL Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 1.0mL ANA Homogeneous Pattern 4. 1x 1.0mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 10mL Mounting Medium 7. 1x 25 Coverslips

INOVA DIAGNOSTICS, INC.

Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 08426950514008
• NIH Device Record Key: f11c28c4-8712-484c-baf1-92b67b21ed0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA Lite® ANA KSL Kit
• Version Model Number: 708380
• 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
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: support@inovadx.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950514008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901596

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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: 2021-06-08
• Device Publish Date: 2016-08-31

On-Brand Devices [NOVA Lite® ANA KSL Kit]

• 08426950514008: 1. 25x 8-well ANA KSL Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 1.0mL ANA
• 08426950506324: 1. 10x 4-well ANA KSL Substrate Slides 2. 1x 7mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL ANA