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

GUDID 10190302000505

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD PCR instrument calibrator kit IVD 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

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

• 10190302019514 - Diomni™ Software, Version 4.1.0: 2024-05-06
• 10190302019231 - KingFisher™ Apex Dx Purification Instrument: 2023-08-11
• 10190302019248 - KingFisher™ Apex Dx 96 PCR Head: 2023-08-11
• 10190302019255 - KingFisher™ Apex Dx 96 Combi Head: 2023-08-11
• 10190302019262 - KingFisher™ Apex Dx 96 Deep Well Head: 2023-08-11
• 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