corQC EXTEND Standard 0066296

GUDID 10888234001324

corQC EXTEND Standard is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents.

IMMUCOR, INC.

Multiple immunohaematology test IVD, control

• Primary Device ID: 10888234001324
• NIH Device Record Key: f2c709e8-7c5e-426c-858c-822e48c33c97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: corQC EXTEND Standard
• Version Model Number: 0066296
• Catalog Number: 0066296
• 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
• 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: 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	10888234001324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070039

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-14

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