Panoscreen EXTEND

GUDID 10888234002406

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.

IMMUCOR, INC.

Antibody identification panel reagent red blood cell IVD, kit, agglutination

• Primary Device ID: 10888234002406
• NIH Device Record Key: 9adb0473-c4df-4934-99fb-146fffb6b937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoscreen EXTEND
• Version Model Number: 0002383
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002406 [Primary]

FDA Product Code

• QHT: Reagent Red Blood Cells

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: 2019-10-31
• Device Publish Date: 2019-10-23

Devices Manufactured by IMMUCOR, INC.

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