Anti-k (Monoclonal) (IgG) Gamma-clone 0004817

GUDID 10888234002390

Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial.

IMMUCOR, INC.

Anti-k (KEL002) red blood cell grouping IVD, antibody

• Primary Device ID: 10888234002390
• NIH Device Record Key: f50c4007-dc9b-4b3d-9542-b4850a896665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-k (Monoclonal) (IgG) Gamma-clone
• Version Model Number: 0004817
• Catalog Number: 0004817
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002390 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

Devices Manufactured by IMMUCOR, INC.

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