3500 Dx CS2 Genetic Analyzer 8-capillary

GUDID 10190302000642

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid sequence analyser IVD, Sanger sequencing

• Primary Device ID: 10190302000642
• NIH Device Record Key: 4d2a3c7b-374c-45cf-881c-36e8862a2c02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3500 Dx CS2 Genetic Analyzer 8-capillary
• Version Model Number: 3500DxCS2
• 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	10190302000642 [Primary]

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: 4
• Public Version Date: 2019-10-21
• Device Publish Date: 2016-08-01

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