Anti-Cw (Monoclonal) Gamma-clone 0004819

GUDID 10888234002376

Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Cw (RH8) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.

IMMUCOR, INC.

Anti-C^w red blood cell grouping IVD, antibody

• Primary Device ID: 10888234002376
• NIH Device Record Key: 06dfe6ab-21a1-4140-b8e6-5cb4590a8938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Cw (Monoclonal) Gamma-clone
• Version Model Number: 0004819
• Catalog Number: 0004819
• 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	10888234002376 [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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• 10888234002291 - Capture LISS: 2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%).
• 10888234002307 - Capture-R Ready Indicator Red Cells: 2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays
• 10888234002314 - Capture-P Indicator Red Cells: 2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
• 10888234001522 - Referencells: 2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.