PIFA® Heparin/PF4 Rapid Assay 4036025

GUDID 00708872615123

A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA® Heparin/PF4 Rapid Assay.

AKERS BIOSCIENCES, INC.

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

• Primary Device ID: 00708872615123
• NIH Device Record Key: 4df925c9-bca8-4336-a533-f6bc1b97ff1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIFA® Heparin/PF4 Rapid Assay
• Version Model Number: 4036025
• Catalog Number: 4036025
• Company DUNS: 611245549
• Company Name: AKERS BIOSCIENCES, INC.
• Device Count: 6
• 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

Customer Support Contacts

• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.com
• Phone: 856-848-8698
• Email: sandrelczyk@akersbio.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00708872615123 [Primary]
GS1	01708872615123 [Unit of Use]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by AKERS BIOSCIENCES, INC.

• 00708872000004 - Heparin/PF4 Antibody Serum Panel: 2018-07-06 The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and
• 00708872000011 - Heparin/PF4 Antibody Serum Panel: 2018-07-06 The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and
• 00708872615124 - PIFA PLUSS® PF4 Rapid Assay: 2018-07-05 A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to
• 00708872615123 - PIFA® Heparin/PF4 Rapid Assay: 2018-03-29A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA® Heparin/PF4 Rapid Assay.
• 00708872615123 - PIFA® Heparin/PF4 Rapid Assay: 2018-03-29 A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to