QUANTA Flash® Calprotectin Controls

GUDID 08426950928782

1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin High Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives.

INOVA DIAGNOSTICS, INC.

Calprotectin IVD, control

• Primary Device ID: 08426950928782
• NIH Device Record Key: 74994559-37d2-4460-b25c-1752147f2fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA Flash® Calprotectin Controls
• Version Model Number: 701352
• 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	08426950928782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170993

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-06
• Device Publish Date: 2018-02-28

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