Ion PGM™ Dx Chip Minifuge

GUDID 10190302000840

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD

• Primary Device ID: 10190302000840
• NIH Device Record Key: 61992535-89ac-4bde-b13d-46f8b782ce39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion PGM™ Dx Chip Minifuge
• Version Model Number: 6431
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• 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: false
• Serial Number: true
• 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	10190302000840 [Primary]

FDA Product Code

• PFF: High throughput DNA sequence analyzer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-08-01

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• 10190302019279 - KingFisher™ Apex Dx 24 Combi Head: 2023-08-11
• 10190302019408 - Diomni™ Software, Version 4.0.0: 2023-07-20
• 10190302018944 - VeritiPro Dx Thermal Cycler: 2023-06-02