Respiratory Pathogens Flex (RP Flex) Amplification Tray

GUDID 00857573006324

The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.

NANOSPHERE, INC.

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00857573006324
• NIH Device Record Key: 8cbaaa2f-3d77-464e-a880-1d0838d5a198
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Respiratory Pathogens Flex (RP Flex) Amplification Tray
• Version Model Number: 20-011-024
• 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
• 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
• 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
• 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
• 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	00840487101711 [Primary]
GS1	00857573006324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143653

FDA Product Code

• OEP: Influenza a virus subtype differentiation nucleic acid assay
• OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay

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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• 00857573006119 - Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge: 2019-12-06 The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System i