Positive Serum Control 403625

GUDID 10888234500438

For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

IMMUCOR GTI DIAGNOSTICS, INC.

Platelet factor 4-heparin complex total antibody IVD, kit, agglutination, rapid Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control Platelet factor 4 IVD, control

• Primary Device ID: 10888234500438
• NIH Device Record Key: 63ec7fbe-1995-4dc5-a017-18c9dcd4fbc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positive Serum Control
• Version Model Number: 403625
• Catalog Number: 403625
• Company DUNS: 606034197
• Company Name: IMMUCOR GTI DIAGNOSTICS, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.co
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053559

FDA Product Code

• LCO: Platelet Factor 4 Radioimmunoassay

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: 2016-07-08

On-Brand Devices [Positive Serum Control]

• 10888234500643: For Use with PakPlus
• 10888234500636: For Use with PakAuto
• 10888234500629: For Use with Pak2-LE
• 10888234500612: For Use with Pak12G
• 10888234500605: For Use with Pak12
• 10888234500438: For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)