Savanna 20445

GUDID 30014613340119

Savanna HSV 1+2/VZV Assay

DIAGNOSTIC HYBRIDS, INC.

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30014613340119
• NIH Device Record Key: 0c4f1903-edaf-4624-b0de-f28802fc991f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Savanna
• Version Model Number: 20445
• Catalog Number: 20445
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613340119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232286

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: 2024-05-08
• Device Publish Date: 2024-04-30

On-Brand Devices [Savanna]

• 30014613340492: Savanna HSV 1+2/VZV Control Set
• 30014613340485: Savanna HSV 1+2/VZV Control Set
• 30014613340119: Savanna HSV 1+2/VZV Assay
• 30014613339304: Savanna Instrument
• 30014613340089: Savanna Instrument