AccessGUDID - DEVICE: Heparin/PF4 Antibody Serum Panel (00708872000004)

GUDID

Device Identifier (DI) Information

Brand Name: Heparin/PF4 Antibody Serum Panel
Version or Model: 4036027
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4036027
Company Name: AKERS BIOSCIENCES, INC.

Primary DI Number: 00708872000004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 611245549 *Terms of Use

Device Description: The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60534	Platelet factor 4-heparin complex antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of antibodies to platelet factor 4-heparin complex in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	Plasma, Coagulation Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052697	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: exactly -70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8aba698e-c39e-417c-a287-24b219de73fa
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 05, 2018