StaphTEX™

Basic Information

• Brand Name: StaphTEX™
• Primary DI: 00819398028059
• Version / Model: ST1000
• Catalog Number: ST1000
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 1
• Public Version Date: 2022-12-01
• Public Version Status: New
• Public Device Record Key: 38326b78-449f-494a-96ee-e86728648327

Device Description

StaphTEX™ Blue test kit, 1000 tests. A rapid, latex agglutination slide-card test for the detection of coagulase clumping factor and/or protein A characteristics associated with Staphylococcus aureus.

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
51659	Staphylococcus aureus culture isolate 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 Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398028011	GS1
Primary	00819398028059	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius