Fast 96-Well Normalization Plates with FAM™/ROX™ and VIC™/ROX™ Dyes

GUDID 10190302000505

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

PCR instrument calibrator kit IVD

• Primary Device ID: 10190302000505
• NIH Device Record Key: 85eee70f-7b92-46ac-b324-36fda18f06ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fast 96-Well Normalization Plates with FAM™/ROX™ and VIC™/ROX™ Dyes
• Version Model Number: 4443774
• 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: 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	10190302000505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123955

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-18
• Device Publish Date: 2016-08-01

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