Respiratory Virus Panel Antigen Control Slide, 14 wells QRP-6314

GUDID B110QRP63140

Bion Enterprises, Ltd.

Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control

• Primary Device ID: B110QRP63140
• NIH Device Record Key: 190edcd3-aea8-455e-b14d-0273c6e9687b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respiratory Virus Panel Antigen Control Slide, 14 wells
• Version Model Number: QRP-6314
• Catalog Number: QRP-6314
• Company DUNS: 024824641
• Company Name: Bion Enterprises, Ltd.
• 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: false
• 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: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B110QRP63140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890616

FDA Product Code

• LJG: Quality Control Slides

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: 2020-03-04
• Device Publish Date: 2016-09-12

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