Oncomine™ Dx Target Test User Guide and Assay Definition File

GUDID 10190302015646

LIFE TECHNOLOGIES CORPORATION

Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software

• Primary Device ID: 10190302015646
• NIH Device Record Key: f8c9a874-da13-4ed8-87df-da9226b37931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncomine™ Dx Target Test User Guide and Assay Definition File
• Version Model Number: A49678
• 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: false
• 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	10190302015646 [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: 2
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-01-14

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

• 10190302010320 - Human CD138 R-PE Conjugate: 2023-11-30
• 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