Oncomine™ Dx Target DNA Control Kit

GUDID 10190302006095

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control

• Primary Device ID: 10190302006095
• NIH Device Record Key: 7eb0fbb9-c75f-4213-8581-90d368523cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncomine™ Dx Target DNA Control Kit
• Version Model Number: A32442
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302006095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160045

FDA Product Code

• PQP: Next generation sequencing oncology panel, somatic or germline variant detection system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-06-27

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