QUANTA Flash® β2GPI IgG Reagents

GUDID 08426950594420

1. QUANTA Flash β2GP1 IgG Reagent Cartridge 1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2

INOVA DIAGNOSTICS, INC.

Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08426950594420
• NIH Device Record Key: 5a6fcb9e-e71f-40d5-b362-cdaa54cf4b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Flash® β2GPI IgG Reagents
• Version Model Number: 701248
• 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	08426950594420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091556

FDA Product Code

• MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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

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