Ion PGM™ 318 Dx Chip Kit

GUDID 10190302006255

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302006255
• NIH Device Record Key: 87e6b41e-b4b4-40f8-bbf4-6c9c1631b5e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion PGM™ 318 Dx Chip Kit
• Version Model Number: A18937
• 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: true
• 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	10190302006255 [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

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