Prolex E. coli O157 Latex Reagent Control Negative

Basic Information

• Brand Name: Prolex E. coli O157 Latex Reagent Control Negative
• Primary DI: 10628429001100
• Version / Model: PL.076B
• Catalog Number: PL.076B
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-26
• Public Version: 1
• Public Version Date: 2023-01-03
• Public Version Status: New
• Public Device Record Key: f17da96d-9e40-4423-9c5c-848724408673

Device Description

Negative Control Latex Reagent

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
GNA	Antisera, All Types, Escherichia Coli	Microbiology	866.3255	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50913	Escherichia coli antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10628429001100	GS1