PIFA® Heparin/PF4 Rapid Assay

Basic Information

• Brand Name: PIFA® Heparin/PF4 Rapid Assay
• Primary DI: 00708872615123
• Version / Model: 4036025
• Catalog Number: 4036025
• Company Name: AKERS BIOSCIENCES, INC.
• Labeler DUNS: 611245549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 4df925c9-bca8-4336-a533-f6bc1b97ff1f

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	864.7695	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61512	Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative 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 a rapid agglutination method. This is a rapid test commonly used in a laboratory or in point-of-care analyses to aid in the investigation/diagnosis of heparin induced thrombocytopenia (HIT). It is not intended to be used for self-testing	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00708872615123	GS1
Unit of Use	01708872615123	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius