Oncomine™ Dx Target Test User Guide and Assay Definition File

GUDID 10190302015646

LIFE TECHNOLOGIES CORPORATION

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

• 10190302005197 - Aim -V™ Medium: 2024-06-04 AIM V MED
• 10190302012041 - Human CD99 FITC Conjugate: 2024-06-04 HU CD99 3B2/TA8 FITC MAB
• 10190302012058 - Human CD99 R-PE Conjugate: 2024-06-04 HU CD99 3B2/TA8 PE MAB
• 10190302012065 - Human CXCR4 (CD184) R-PE Conjugate: 2024-06-04 HU CXCR4 12G5 PE MAB
• 10190302012164 - Anti-Human HLA-DR (Class II) FITC Conjugate: 2024-06-04 HU HLA-DR TU36 FITC MAB
• 10190302012171 - Anti-Human HLA-DR (Class II) R-PE Conjugate: 2024-06-04 HU HLA-DR TU36 PE MAB
• 10190302012188 - Anti-Human HLA-DR (Class II) APC Conjugate: 2024-06-04 HU HLA-DR TU36 APC MAB
• 10190302012195 - Anti-Human HLA-DR (Class II) PE-Texas Red® Conjugate: 2024-06-04 HU HLA-DR TU36 PE-TX RED MAB