Fast 96-Well Block

GUDID 10190302000598

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302000598
• NIH Device Record Key: d416988e-f14a-4c0d-8c6d-f193f08dd6d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fast 96-Well Block
• Version Model Number: 7821
• 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	10190302000598 [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: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-01

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• 10190302019408 - Diomni™ Software, Version 4.0.0: 2023-07-20
• 10190302018944 - VeritiPro Dx Thermal Cycler: 2023-06-02