Solana M302

GUDID 30014613336105

Solana HSV 1+2/ VZV Assay

DIAGNOSTIC HYBRIDS, INC.

Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30014613336105
• NIH Device Record Key: 0d228866-44c1-4b3f-b793-2242fe3d22d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solana
• Version Model Number: M302
• Catalog Number: M302
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613336105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162451

FDA Product Code

• PGI: Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [Solana]

• 30014613336440: Solana GBS Assay
• 30014613337003: Solana RSV+hMPV Control Set
• 30014613336990: Solana Flu A+B Control Set
• 30014613336983: Solana HSV 1+2/ VZV Control set
• 30014613336150: Solana C. difficile Assay
• 30014613336143: Solana RSV/hMPB Assay
• 30014613336136: Solana Strep A/C & G Assay
• 30014613336105: Solana HSV 1+2/ VZV Assay
• 30014613336068: Solana Infulenza A+B Assay
• 30014613336167: Solana Bordetella Complete