Prolex Streptococcal Grouping Reagent Polyvalent Positive Control

Basic Information

• Brand Name: Prolex Streptococcal Grouping Reagent Polyvalent Positive Control
• Primary DI: 10628429000271
• Version / Model: PL.040
• Catalog Number: PL.040
• 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: e21df79a-2b7a-4219-9fc6-3c28c91acaa9

Device Description

StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control for the rapid latex agglutination test for the identification of streptococcal groups.

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
43586	Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10628429000271	GS1