Alpha-Tec Systems

Basic Information

• Brand Name: Alpha-Tec Systems
• Primary DI: 00816085020495
• Version / Model: 0
• Catalog Number: 0003238
• Company Name: Alpha-TEC Systems, Inc.
• Labeler DUNS: 103105524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2022-07-20
• Public Version: 1
• Public Version Date: 2022-07-28
• Public Version Status: New
• Public Device Record Key: e65b46c6-46eb-4ecb-95cf-2257f6afa178

Device Description

Gram Stain Control Slide

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: No
• 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
Unit of Use	00816085020129	GS1
Primary	00816085020495	GS1

Premarket Submissions

Submission Number	Supplement Number
K823704	000