Solana M308

GUDID 30014613336167

Solana Bordetella Complete

DIAGNOSTIC HYBRIDS, INC.

Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30014613336167
• NIH Device Record Key: 9a928115-59b8-4552-87e6-08923aaaba4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solana
• Version Model Number: M308
• Catalog Number: M308
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613336167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181029

FDA Product Code

• OZZ: Bordetella pertussis dna assay system

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: 2020-02-12
• Device Publish Date: 2020-02-04

On-Brand Devices [Solana]

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• 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