Ion One Touch™ ES Dx

GUDID 10190302000864

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 10190302000864
• NIH Device Record Key: 7b937530-4c89-4991-a0ea-b8629214e3b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion One Touch™ ES Dx
• Version Model Number: ONE TOUCH ES DX
• 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: 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	10190302000864 [Primary]

FDA Product Code

• PFF: High throughput DNA sequence 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: 4
• Public Version Date: 2020-07-07
• Device Publish Date: 2016-08-01

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

• 10190302007399 - Array Card Clip: 2024-06-04 VIIA 7 DX ARRAY CARD BUCKET
• 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