3500 xL Dx CS2 Genetic Analyzer 24-capillary

GUDID 10190302000659

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing Nucleic acid sequence analyser IVD, Sanger sequencing

• Primary Device ID: 10190302000659
• NIH Device Record Key: 8077530d-6688-4534-aae8-7c2a71fb887c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3500 xL Dx CS2 Genetic Analyzer 24-capillary
• Version Model Number: 3500xLDxCS2
• 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	10190302000659 [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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