Lyra M103

GUDID 30014613311034

Lyra RSV+HMPV Assay

DIAGNOSTIC HYBRIDS, INC.

Multiple respiratory virus nucleic acid IVD, reagent Multiple respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent Multiple-genus respiratory virus nucleic acid IVD, reagent

• Primary Device ID: 30014613311034
• NIH Device Record Key: 1d59a408-e314-4a1e-a495-090387d6bf01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyra
• Version Model Number: M103
• Catalog Number: M103
• Company DUNS: 117359612
• Company Name: DIAGNOSTIC HYBRIDS, 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: true
• 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: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613311034 [Primary]

FDA Product Code

• OEM: Human metapneumovirus (hmpv) rna assay system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Lyra]

• 30014613311034: Lyra RSV+HMPV Assay
• 30014613311003: Lyra FLU A+B Assay
• 30014613339144: SARS-CoV-2 Direct Assay
• 30014613339090: Lyra SARS-CoV-2 Assay