Gram-Positive Blood Culture (BC-GP) Extraction Tray

Basic Information

• Brand Name: Gram-Positive Blood Culture (BC-GP) Extraction Tray
• Primary DI: 00857573006218
• Version / Model: 20-009-018
• Company Name: NANOSPHERE, INC.
• Labeler DUNS: 164757242
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 3525ba02-7325-4879-82fb-5ff62929e74a
• Distribution End Date: 2019-12-05

Device Description

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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	866.1640	2
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	866.3365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61308	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857573006218	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius