Human CD3 R-PE Conjugate

GUDID 10190302005371

LIFE TECHNOLOGIES CORPORATION

CD3 cell marker IVD, antibody

• Primary Device ID: 10190302005371
• NIH Device Record Key: 086069ca-cac3-4013-ba56-c2e63281d8fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human CD3 R-PE Conjugate
• Version Model Number: MHCD0304
• 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	10190302005371 [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: 2019-10-21
• Device Publish Date: 2016-08-01

On-Brand Devices [Human CD3 R-PE Conjugate]

• 10190302008440: CD0304
• 10190302005371: MHCD0304
• 10190302008914: GM40135