INFINITI® Factor II BioFilmChip® Microarray Magazine 01-1020-01

GUDID 00850009370044

Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.

AUTOGENOMICS, INC

Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00850009370044
• NIH Device Record Key: ea6b0e03-c3db-4766-a5f3-ea3f4daaa65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITI® Factor II BioFilmChip® Microarray Magazine
• Version Model Number: 01-1020-01
• Catalog Number: 01-1020-01
• Company DUNS: 027914535
• Company Name: AUTOGENOMICS, INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com
• Phone: +1(760)477-2248
• Email: techsupport@autogenomics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850009370044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060564

FDA Product Code

• NPR: TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

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: 2019-10-31
• Device Publish Date: 2019-10-23

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• 30850009370250 - AvertD™ (96) AMP Mix: 2024-11-26 The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qua
• 10850009370195 - AvertD™ Amplification Mix: 2024-06-10 The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qua
• 10850009370201 - AvertD™ Intellipac Reagent Module: 2024-06-10 The Intellipac Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer
• 10850009370218 - AvertD™ BioFilmChip Microarray Magazine: 2024-06-10 The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis
• 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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