GenetiSure Dx Labeling Kit Purification Columns

GUDID 05700571112618

GenetiSure Dx Labeling Kit Purification Columns

AGILENT TECHNOLOGIES, INC.

Intellectual/developmental disability nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 05700571112618
• NIH Device Record Key: a15149c5-1e37-496d-a24f-ba1d3153f207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenetiSure Dx Labeling Kit Purification Columns
• Version Model Number: K1201-64110
• Company DUNS: 003454332
• Company Name: AGILENT TECHNOLOGIES, 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: 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: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com
• Phone: +1-877-424-4536
• Email: contact_us@agilent.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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	05700571112618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163367

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: 2018-07-06
• Device Publish Date: 2017-11-08

Devices Manufactured by AGILENT TECHNOLOGIES, INC.

• 05700573007400 - MAGE-A4 IHC 1F9 pharmDx: 2024-10-09 MAGE-A4 IHC 1F9 pharmDx
• 05700571112342 - Dako: 2024-08-15 Dako Omnis Vial with Mixing Ball, 2 mL
• 05700571112311 - Dako: 2024-08-15 Dako Omnis Small Vial, 2 mL
• 05700571112328 - Dako: 2024-08-15 Dako Omnis Large Vial, 30 mL
• 05700574037420 - SureFISH 13q14.2 RB1 522kb P20 GR: 2024-06-17 SureFISH 13q14.2 RB1 522kb P20 GR
• 05700574007164 - 406FX-SI: 2023-04-04 Microplate Washer Dispenser
• 05700574034320 - BSTCK2WR-SI: 2023-04-04 Microplate Stacker
• 05700574034337 - BSTCK3WR-SI: 2023-04-04 Microplate Stacker