Alpha-Tec Systems

Basic Information

• Brand Name: Alpha-Tec Systems
• Primary DI: 00816085022178
• Version / Model: 0
• Catalog Number: 0003724
• Company Name: Alpha-TEC Systems, Inc.
• Labeler DUNS: 103105524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 32
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 1
• Public Version Date: 2022-08-18
• Public Version Status: New
• Public Device Record Key: d4279783-ae6f-4e4f-a988-48a542fc3b83

Device Description

PVA(Zn)/10% Formalin/ETM Microvials

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
LDZ	Fixative, Alcohol Containing	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61352	Faecal specimen collection kit IVD, home-use	A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816085022277	GS1
Primary	00816085022178	GS1

Premarket Submissions

Submission Number	Supplement Number
K881698	000