DiskFISH DF40059

GUDID M663DF400590

DiskFISH Disks (3Gd, 6A, 7Gr, 20R)

CELLAY, INC.

Nucleic acid hybridization detection IVD, probe

• Primary Device ID: M663DF400590
• NIH Device Record Key: 3f754915-7036-49d9-99e2-cee68a4c70a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiskFISH
• Version Model Number: DF40059
• Catalog Number: DF40059
• Company DUNS: 831148692
• Company Name: CELLAY, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.com
• Phone: 6172717003
• Email: customer.support@cellayinc.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
• 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
HIBCC	M663DF400590 [Unit of Use]
HIBCC	M663DF4005901001 [Primary]
HIBCC	M663DF400599 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2026-01-14
• Device Publish Date: 2026-01-06

On-Brand Devices [DiskFISH]

• M663DF402440: DiskFISH Disks (7Gr, 16A, 18R, 20Gd)
• M663DF400590: DiskFISH Disks (3Gd, 6A, 7Gr, 20R)
• M663DF300129: DiskFISH Disks (XR, YGr, 18A)
• M663DF300120: DiskFISH Disks (XR, YGr, 18A)