GenetiSure Dx Labeling Kit

GUDID 05700571112601

GenetiSure Dx Labeling Kit

AGILENT TECHNOLOGIES, INC.

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

• Primary Device ID: 05700571112601
• NIH Device Record Key: a1478ae1-f5ee-496d-a5f2-cbc3bd796757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenetiSure Dx Labeling Kit
• Version Model Number: K1201-64105
• 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
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• 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
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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 -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700571112601 [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: 2017-11-07

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