AccessGUDID - DEVICE: Platelet PGDprime Reagent 2 (10850046056038)

GUDID

Device Identifier (DI) Information

Brand Name: Platelet PGDprime Reagent 2
Version or Model: P01214
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Verax Biomedical Incorporated

Primary DI Number: 10850046056038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102312712 *Terms of Use

Device Description: Platelet PGDprime Reagent 2 required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.

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:	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?
66552	Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of the highly conserved bacterial antigens lipoteichoic acid (LTA) and lipopolysaccharide (LPS) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect gram-negative or gram-positive bacterial contamination of blood products (e.g., platelets). It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZC	System, Detection, Bacterial, For Platelet Transfusion Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 301c4bcf-555d-4d13-b8f5-73cfbbfdcb3c
Public Version Date: April 21, 2023
Public Version Number: 1
DI Record Publish Date: April 13, 2023