Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge

GUDID 00857573006119

The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).

NANOSPHERE, INC.

Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00857573006119
• NIH Device Record Key: af2b1e0d-a701-4c69-93fa-2e5d80d5722a
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
• Version Model Number: 20-006-018
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101575 [Primary]
GS1	00857573006119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN120014

FDA Product Code

• NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
• PAM: Gram-positive bacteria and their resistance markers

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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• 00857573006041 - Enteric Pathogens (EP) Nucleic Acid Test Cartridge: 2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identi
• 00857573006058 - Enteric Pathogens (EP) Extraction Tray: 2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and iden
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• 00857573006089 - Enteric Pathogens (EP) Amplification Tray: 2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and iden
• 00857573006119 - Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge: 2019-12-06The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
• 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