Human CD3 TRI-COLOR® Conjugate

GUDID 10190302005401

LIFE TECHNOLOGIES CORPORATION

CD3 cell marker IVD, antibody CD3 cell marker IVD, antibody CD3 cell marker IVD, antibody CD3 cell marker IVD, antibody CD3 cell marker IVD, antibody

• Primary Device ID: 10190302005401
• NIH Device Record Key: b72332af-f53e-4ec7-bcec-05265672c883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human CD3 TRI-COLOR® Conjugate
• Version Model Number: MHCD03065
• Company DUNS: 080131636
• 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	10190302005401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944127

FDA Product Code

• GKZ: Counter, differential cell

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: 2019-05-08
• Device Publish Date: 2016-08-01

On-Brand Devices [Human CD3 TRI-COLOR® Conjugate]

• 10190302005401: MHCD03065
• 10190302005395: MHCD0306