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

Basic Information

• Brand Name: Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
• Primary DI: 00840487101575
• Version / Model: 20-006-018
• Catalog Number: 20-006-018
• Company Name: LUMINEX CORPORATION
• Labeler DUNS: 080778937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-05
• Public Version: 3
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: c237ef1b-3fec-468d-819d-ec807e3c597c

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
PAM	Gram-positive bacteria and their resistance markers	Microbiology	866.3365	2
NQX	SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62484	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	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 technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	00857573006119	GS1
Primary	00840487101575	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius