QUANTA Flash® aCL IgG Reagents

GUDID 08426951289295

1. 1 QUANTA Flash aCL IgG Reagent Cartridge 2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2

INOVA DIAGNOSTICS, INC.

Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08426951289295
• NIH Device Record Key: 6617273e-63d7-4e5a-b8e7-3ad2dc32799d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Flash® aCL IgG Reagents
• Version Model Number: 701230
• 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	08426951289295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092181

FDA Product Code

• MID: System, Test, Anticardiolipin Immunological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-27

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