Human CD3 TRI-COLOR® Conjugate

GUDID 10190302005395

LIFE TECHNOLOGIES CORPORATION

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

• Primary Device ID: 10190302005395
• NIH Device Record Key: 626232c2-2c84-4365-bfec-97ff6f005041
• Commercial Distribution Discontinuation: 2022-04-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Human CD3 TRI-COLOR® Conjugate
• Version Model Number: MHCD0306
• 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	10190302005395 [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: 6
• Public Version Date: 2022-05-23
• Device Publish Date: 2016-08-01

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

• 10190302005401: MHCD03065
• 10190302005395: MHCD0306