Solana M304.U

GUDID 30014613336402

SolanaTrichomonas Assay

QUIDEL CORPORATION

Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30014613336402
• NIH Device Record Key: 9026dad5-e762-4b8d-abe6-a8d09762e62b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solana
• Version Model Number: Trichomonas Assay
• Catalog Number: M304.U
• Company DUNS: 079509836
• Company Name: QUIDEL CORPORATION
• 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

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	30014613336402 [Primary]

FDA Product Code

• OUY: Trichomonas vaginalis nucleic acid amplification test 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: 2016-09-16

On-Brand Devices [Solana]

• 30014613336402: SolanaTrichomonas Assay
• 30014613336396: Solana Trichomonas Assay
• 30014613336082: Solana GAS Assay
• 30014613202783: Solana instrument