H.P.C. (Human Platelet Concentrate) 0057320

GUDID 10888234001027

H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C

IMMUCOR, INC.

Multiple human platelet antigen (HPA) typing IVD, kit, agglutination

• Primary Device ID: 10888234001027
• NIH Device Record Key: 4f58da61-ab5b-4ec4-8603-637280b534c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.P.C. (Human Platelet Concentrate)
• Version Model Number: 0057320
• Catalog Number: 0057320
• 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: false
• 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	10888234001027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK850008

FDA Product Code

• MYP: Test,Platelet Antibody

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: 2016-04-18

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