Applied Biosystems 610525

GUDID 00856826006210

Chromosome Analysis Suite Dx Software

AFFYMETRIX, INC.

Human genomic analysis interpretive software

• Primary Device ID: 00856826006210
• NIH Device Record Key: f14f1174-952e-4d3e-a19e-eb64d9608727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applied Biosystems
• Version Model Number: 2.1
• Catalog Number: 610525
• Company DUNS: 804682573
• Company Name: AFFYMETRIX, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856826006210 [Primary]

FDA Product Code

• PFX: System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

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: 2024-11-07
• Device Publish Date: 2024-10-30

Devices Manufactured by AFFYMETRIX, INC.

• 00856826006210 - Applied Biosystems: 2024-11-07Chromosome Analysis Suite Dx Software
• 00856826006210 - Applied Biosystems: 2024-11-07 Chromosome Analysis Suite Dx Software
• 00856826006104 - CytoScan Dx WS A: 2020-02-10
• 00856826006029 - Affymetrix: 2018-03-29
• 00856826006036 - Affymetrix: 2018-03-29
• 00856826006043 - Affymetrix: 2018-03-29
• 00856826006050 - Affymetrix: 2018-03-29
• 00856826006067 - Affymetrix: 2018-03-29
• 00856826006074 - Affymetrix: 2018-03-29