AccessGUDID - DEVICE: PakPlus® (10888234500674)

GUDID

Device Identifier (DI) Information

Brand Name: PakPlus®
Version or Model: PAKPLUS100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PAKPLUS100
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234500674
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
56579	Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYP	Test,Platelet Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK140163	0

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: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f81ee971-391b-4415-bad7-5f9f7b998b65
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2016