Ion Torrent™ Dx No Template Control Kit

GUDID 10190302006156

LIFE TECHNOLOGIES CORPORATION

PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD PCR/NAT negative control IVD

• Primary Device ID: 10190302006156
• NIH Device Record Key: 125415a3-f03b-4bb4-b130-2c4d8462fea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion Torrent™ Dx No Template Control Kit
• Version Model Number: A32444
• 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	10190302006156 [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: 6
• Public Version Date: 2020-09-29
• Device Publish Date: 2017-06-27

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

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• 10190302010337 - Human CD138 PE-Cy®5.5 Conjugate: 2023-11-30
• 10190302011730 - Human CD61 APC Conjugate: 2023-11-30
• 10190302000680 - 3500Dx Series Polymer Pouch Caps: 2023-11-20
• 10190302000116 - Histostain® Plus Broad Spectrum: 2023-10-18
• 10190302000123 - invitrogen: 2023-10-18
• 10190302000130 - invitrogen: 2023-10-18
• 10190302008242 - Histostain® Plus 3rd Gen IHC Detection Kit (1000 Slides): 2023-10-18