Alpha-Tec Systems

Basic Information

• Brand Name: Alpha-Tec Systems
• Primary DI: 00816085022277
• Version / Model: 0
• 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: aa248eb2-5dc4-420f-9a43-c26ff3bafe20

Device Description

PVA(Zn)/10% Formalin/ETM Microvials bag kit

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
Primary	00816085022277	GS1

Premarket Submissions

Submission Number	Supplement Number
K881698	000