Oncomine™ Dx Target Test

GUDID 10190302015103

LIFE TECHNOLOGIES CORPORATION

Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent Multiple tissue-associated protein/tumour marker IVD, reagent

• Primary Device ID: 10190302015103
• NIH Device Record Key: dbb11fce-bd4d-4b46-9312-2b20e91e9676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncomine™ Dx Target Test
• Version Model Number: A32441
• 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	10190302015103 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

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