Fecal Extraction Device

GUDID 08426950846833

-100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps

INOVA DIAGNOSTICS, INC.

Plasma protein IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 08426950846833
• NIH Device Record Key: 7c7c3833-a787-40b6-893d-29f8acfbed1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fecal Extraction Device
• Version Model Number: 504837
• 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: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 18005459495
• Email: support@inovadx.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.com
• Phone: 1-800-545-9495
• Email: TechSupport.na@werfen.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
• 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
• 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
• 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	08426950846833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180971

FDA Product Code

• NXO: Calprotectin, Fecal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-08-20
• Device Publish Date: 2018-11-30

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• 08426950627692 - QUANTA Flash PR3 Reagents: 2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge