Sequencing Standard v1.1, 3500 Dx Series

GUDID 10190302000673

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

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• Primary Device ID: 10190302000673
• NIH Device Record Key: 3311d337-8d73-4a2f-8f11-cfd93757960d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sequencing Standard v1.1, 3500 Dx Series
• Version Model Number: 4462113
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• Device Count: 4
• 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	10190302000673 [Primary]
GS1	80190302000672 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK110039

FDA Product Code

• PCA: DNA genetic 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: 7
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-03

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

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• 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
• 10190302018869 - 384-Well Spectral Calibration Plate with Cy®5 Dye: 2023-04-07