Ion OneTouch™ Dx Sequencing Reagents

GUDID 10190302006224

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302006224
• NIH Device Record Key: 38e091af-e5ee-4f24-80da-e28227645388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion OneTouch™ Dx Sequencing Reagents
• Version Model Number: A18934
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	10190302006224 [Primary]

FDA Product Code

• PFT: Reagents for molecular diagnostic test systems

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-04-14

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