NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach

GUDID 08426950593539

1. 20x 8-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips

INOVA DIAGNOSTICS, INC.

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

• Primary Device ID: 08426950593539
• NIH Device Record Key: 63d3359d-95cd-4a3e-ab7e-ca8920f9764f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach
• Version Model Number: 708150
• 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	08426950593539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881339

FDA Product Code

• LLL: Extractable Antinuclear Antibody, Antigen And 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® HEp-2 ANA Plus Mouse Kidney & Stomach]

• 08426950596387: 1. 20x 4-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA
• 08426950593539: 1. 20x 8-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA