Veri-Q Self-Testing and Veri-Q Plus Mgd-2001 Blood Glucose Monitoring Systems
510(k) K123016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123016 | Date18 Jun 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VERI-Q MGD-2001 Blood Glucose Monitoring System is an in vitro diagnostic device designed for self-testing blood glucose levels outside the body. It is classified as a blood glucose test system and intended for use by individuals with diabetes to monitor their glucose levels at home. The system provides results to aid in managing diabetes control through regular self-monitoring.
This device is supplied as a reusable monitoring system with disposable test strips and lancets. It has received FDA 510(k) clearance under the product code NBW, classified as a Class II device under special controls. The system is intended for over-the-counter use and was determined to be substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data.
Other devices from Mico Biomed Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the VERI-Q MGD-2001 Blood Glucose Monitoring System used for?
The VERI-Q MGD-2001 is designed for self-testing blood glucose levels outside the body. It is intended for individuals with diabetes to monitor their glucose levels at home, helping them manage diabetes control through regular self-monitoring. This allows users to track their blood sugar trends and make informed decisions about their treatment and lifestyle.
How is the VERI-Q MGD-2001 Blood Glucose Monitoring System supplied?
The system is supplied as a reusable monitoring device paired with disposable test strips and lancets. This means the main meter can be reused across multiple testing sessions, while the consumables—test strips and lancets—are single-use items intended for one-time use per test. This design balances convenience with hygiene and cost-effectiveness.
Is the VERI-Q MGD-2001 Blood Glucose Monitoring System sterile?
The available data does not specify whether the device itself is sterile or requires sterilization. However, since it is intended for self-testing at home, the disposable test strips and lancets are likely designed to be sterile for single-use. Users should follow the manufacturer’s instructions for proper handling and disposal to ensure accuracy and safety.
Can the VERI-Q MGD-2001 Blood Glucose Monitoring System be reused?
Yes, the VERI-Q MGD-2001 meter itself is reusable. It is designed to be used repeatedly with compatible disposable test strips and lancets. The reusable nature of the meter helps reduce waste and costs over time, while the single-use consumables ensure each test is accurate and hygienic.
What regulatory approval does the VERI-Q MGD-2001 Blood Glucose Monitoring System hold?
The VERI-Q MGD-2001 Blood Glucose Monitoring System has received FDA 510(k) clearance under product code NBW, classified as a Class II device. This clearance indicates that the device was determined to be substantially equivalent to a predicate device and meets the regulatory requirements for safety and effectiveness as an in vitro diagnostic device.