QUANTA Flash® ENA7 Reagents

GUDID 08426950627821

1. 1 QUANTA Flash ENA7 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet"

INOVA DIAGNOSTICS, INC.

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08426950627821
• NIH Device Record Key: d9dcb69b-4341-4d1b-aab0-e11294d6628e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Flash® ENA7 Reagents
• Version Model Number: 701255
• 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
• 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
• 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	08426950627821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122923

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: 2022-03-08
• Device Publish Date: 2016-08-31

On-Brand Devices [QUANTA Flash® ENA7 Reagents]

• 08426950627821: 1. 1 QUANTA Flash ENA7 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet"
• 08426950566373: 1. 1 QUANTA Flash ENA7 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet"