Hi-Di™ Formamide, 3500 Dx Series

GUDID 10190302000192

LIFE TECHNOLOGIES, CORPORATION

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302000192
• NIH Device Record Key: 679e7790-72af-476b-b8e8-2803535ccf61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hi-Di™ Formamide, 3500 Dx Series
• Version Model Number: 4404307
• Company DUNS: 078441189
• Company Name: LIFE TECHNOLOGIES, CORPORATION
• 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: 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	10190302000192 [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: 7
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-01

Devices Manufactured by LIFE TECHNOLOGIES, CORPORATION

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• 10190302000161 - POP-7 (960) Performance Optimized Polymer, 3500Dx: 2020-04-23
• 10190302059015 - invitrogen: 2019-11-18
• 10190302000154 - POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series: 2019-10-23
• 10190302000178 - POP-6™ (384) Performance Optimized Polymer, 3500 Dx Series: 2019-10-23
• 10190302000246 - Conditioning Reagent, 3500 Dx Series: 2019-10-23