Lyra

Basic Information

• Brand Name: Lyra
• Primary DI: 30014613311003
• Version / Model: M100
• Catalog Number: M100
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2019-06-06
• Public Version Status: Update
• Public Device Record Key: a1f4f714-8bd9-4019-a928-4e84b033675b

Device Description

Lyra FLU A+B Assay

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2
OZE	Influenza A and influenza B multiplex nucleic acid assay	Microbiology	866.3980	2
OCC	Respiratory virus panel nucleic acid assay system	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47277	Influenza A/B virus 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 acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613311003	GS1

Customer Contacts

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