Panoscreen I and II 0002380

GUDID 10888234000297

Panoscreen I and II is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of t

IMMUCOR, INC.

Antibody screening reagent red blood cell IVD, kit, agglutination

• Primary Device ID: 10888234000297
• NIH Device Record Key: 5108ef5b-5649-40b6-ac96-cb31ca1ae343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoscreen I and II
• Version Model Number: 0002380
• Catalog Number: 0002380
• 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: 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: 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	10888234000297 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-04

On-Brand Devices [Panoscreen I and II]

• 10888234000327: This product is used in the detection of unexpected red blood cell blood group antibodies. This
• 10888234000297: Panoscreen I and II is intended for use in the detection of unexpected IgG antibodies to red blo