Alpha-Tec Systems

Basic Information

• Brand Name: Alpha-Tec Systems
• Primary DI: 00816085020167
• Version / Model: 0
• Catalog Number: 0003248S
• Company Name: Alpha-TEC Systems, Inc.
• Labeler DUNS: 103105524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-11
• Public Version: 1
• Public Version Date: 2022-08-19
• Public Version Status: New
• Public Device Record Key: d3c6957a-8a3b-4d42-ad5a-1d5ff9d8604b

Device Description

Nocardia Stain Control Slides

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
LJG	Quality Control Slides	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43510	Biological stain control IVD	A prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816085020167	GS1