AvertD™ Buccal Sample Collection Kit 12-0610-01

GUDID 10850009370225

Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.

AUTOGENOMICS, INC

Oral/upper respiratory tract specimen collection kit IVD, clinical

• Primary Device ID: 10850009370225
• NIH Device Record Key: 895dba6a-3768-489a-9e4d-6fbcb196f31e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AvertD™ Buccal Sample Collection Kit
• Version Model Number: 12-0610-01
• Catalog Number: 12-0610-01
• Company DUNS: 027914535
• Company Name: AUTOGENOMICS, 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: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com
• Phone: 760-477-2248
• Email: techsupport@autogenomics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850009370225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230032

FDA Product Code

• QZH: Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

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: 2024-06-10
• Device Publish Date: 2024-05-31

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• 10850009370225 - AvertD™ Buccal Sample Collection Kit: 2024-06-10 Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15
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