Prolex Staph Xtra Latex Kit (300 tests)

Basic Information

• Brand Name: Prolex Staph Xtra Latex Kit (300 tests)
• Primary DI: 10628429000479
• Version / Model: PL.1081
• Catalog Number: PL.1081
• 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: 19536db7-05de-4cd6-b775-07802ca2141e

Device Description

Staph Xtra Latex Reagent (2 x 2.5 ml) Negative Control Latex Reagent (5.0 ml) Agglutination Cards (20) Mixing Sticks (200)

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: 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
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	866.3700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51656	Multiple Staphylococcus bacterial species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Staphylococcus bacteria or other similar gram positive, catalase positive 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	10628429000479	GS1