Enteric Pathogens (EP) Amplification Tray

GUDID 00857573006089

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.

NANOSPHERE, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray

• Primary Device ID: 00857573006089
• NIH Device Record Key: 04a12f88-76fb-4c9a-895e-6b6567ad0664
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Enteric Pathogens (EP) Amplification Tray
• Version Model Number: 20-011-023
• Company DUNS: 164757242
• Company Name: NANOSPHERE, 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: 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: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: 888-837-4436
• Email: productsupport@nanosphere.us
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101544 [Primary]
GS1	00857573006089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140083

FDA Product Code

• PCH: Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
• PCI: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

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: 2019-12-06
• Device Publish Date: 2016-09-23

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