CytoScan Dx WS A 902090

GUDID 00856826006104

AFFYMETRIX, INC.

Human genomic analysis interpretive software

• Primary Device ID: 00856826006104
• NIH Device Record Key: 31ff3e07-d5c1-45a3-91ca-05bf8854864f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CytoScan Dx WS A
• Version Model Number: 902090
• Catalog Number: 902090
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856826006104 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-10
• Device Publish Date: 2016-09-23

Devices Manufactured by AFFYMETRIX, INC.

• 00856826006203 - Applied Biosystems: 2025-01-01 GeneChip™ Data Collection Dx
• 00856826006210 - Applied Biosystems: 2024-11-07 Chromosome Analysis Suite Dx Software
• 00856826006104 - CytoScan Dx WS A: 2020-02-10
• 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