AmpliVue M211

GUDID 30014613312116

AmpliVue Trichomonas Assay

QUIDEL CORPORATION

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

• Primary Device ID: 30014613312116
• NIH Device Record Key: a90075aa-a41a-4272-a0e8-8a49b74f7f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmpliVue
• Version Model Number: Trichomonas Assay
• Catalog Number: M211
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	30014613312116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143329

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: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [AmpliVue]

• 30014613312123: AmpliVue GAS Assay
• 30014613312116: AmpliVue Trichomonas Assay
• 30014613312109: AmpliVue HSV 1+2 Assay
• 30014613312093: AmpliVue Bordetella Assay
• 30014613312024: AmpliVue GBS Assay
• 30014613312017: AmpliVue CDiff Assay