QUANTA Lite® Celiac DGP Screen ELISA

GUDID 08426950593324

1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Celiac DGP Screen ELISA Low Positive 4. 1x 1.2mL prediluted Celiac DGP Screen ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP Ig G/A Conjugate, (goat), anti-human IgG and IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

INOVA DIAGNOSTICS, INC.

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08426950593324
• NIH Device Record Key: f178d8fc-c9a7-4941-a1e0-80e98227d8b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Lite® Celiac DGP Screen ELISA
• Version Model Number: 704545
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950593324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062708

FDA Product Code

• MST: Antibodies, Gliadin

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: 2022-06-10
• Device Publish Date: 2016-08-31

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