Human CD19 R-PE Conjugate

GUDID 10190302005500

LIFE TECHNOLOGIES CORPORATION

Multiple tissue-associated protein/tumour marker IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 10190302005500
• NIH Device Record Key: 107850ed-be03-478a-99b6-09d2d0ab31ee
• Commercial Distribution Discontinuation: 2022-04-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Human CD19 R-PE Conjugate
• Version Model Number: MHCD19044
• 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	10190302005500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963954

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: 5
• Public Version Date: 2022-05-12
• Device Publish Date: 2016-08-01

On-Brand Devices [Human CD19 R-PE Conjugate]

• 10190302005494: MHCD1904
• 10190302005500: MHCD19044