AmpliVue M212

GUDID 30014613312123

AmpliVue GAS Assay

QUIDEL CORPORATION

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 30014613312123
• NIH Device Record Key: c274905a-e456-4fc3-8c58-6948350a94fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmpliVue
• Version Model Number: Group A Strep Assay
• Catalog Number: M212
• 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
• 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
• 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	30014613312123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141173

FDA Product Code

• PGX: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification 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