MultiCode® BK Virus Primers

Basic Information

• Brand Name: MultiCode® BK Virus Primers
• Primary DI: 00840487101292
• Version / Model: 3908
• Catalog Number: 3908
• Company Name: LUMINEX CORPORATION
• Labeler DUNS: 079686463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f98f916a-6c29-4f05-9117-d15174823fb4

Device Description

Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
MVU	REAGENTS,SPECIFIC,ANALYTE	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49852	BK virus (BKV) nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from BK virus (BKV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840487101292	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius