Platelet PGDprime Test, 20 devices plus disposables

Basic Information

• Brand Name: Platelet PGDprime Test, 20 devices plus disposables
• Primary DI: 10850046056113
• Version / Model: PRM20T
• Catalog Number: PRM20T
• Company Name: Verax Biomedical Incorporated
• Labeler DUNS: 102312712
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-19
• Public Version: 1
• Public Version Date: 2023-04-27
• Public Version Status: New
• Public Device Record Key: ff014e92-04b6-4dc6-adac-78b89033d597

Device Description

Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to run the Platelet PGDprime Test System.

Device Characteristics

• Single Use: No
• 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: Yes
• 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
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850046056113	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius