PIFA® Heparin/PF4 Rapid Assay 4036025

GUDID 00708872615123

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

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

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

LCO	Platelet Factor 4 Radioimmunoassay

Steralize Prior To Use	false
Device Is Sterile	false

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

Mark Image Registration \| Serial	Company Trademark Application Date
PIFA 77893008 3868632 Live/Registered	The Kimmell Center, Inc. 2009-12-14
PIFA 76023159 2713959 Live/Registered	AKERS BIOSCIENCES, INC. 2000-04-10