Prolex Streptococcal Xtra Select Kit

Basic Information

• Brand Name: Prolex Streptococcal Xtra Select Kit
• Primary DI: 10628429001360
• Version / Model: PL.1042
• Catalog Number: PL.1042
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-25
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: 2a9b3d23-9769-495e-8eff-6d3b1e170be8

Device Description

Choose two vials of Group A or B Latex Reagent (3.0ml each) Polyvalent Positive Control (2.0 ml) Extraction Reagent (2 x 8.0 ml) Agglutination Cards (20) Mixing Sticks (150)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51702	Multiple Streptococcus bacterial species culture isolate 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 for the differentiation and/or identification of one or multiple species of Streptococcus bacteria, or other similar gram positive, catalase negative cocci isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10628429001360	GS1