QuantStudio™ 7 Pro Dx Real-Time PCR System

GUDID 10190302016148

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 10190302016148
• NIH Device Record Key: 312613df-eafe-47f5-ac88-4ba580eb6ef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantStudio™ 7 Pro Dx Real-Time PCR System
• Version Model Number: A50745
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• 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: false
• Serial Number: true
• 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	10190302016148 [Primary]

FDA Product Code

• OOI: real time Nucleic acid amplification 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: 2021-12-22
• Device Publish Date: 2021-12-10

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