CMV Antigen Control Slides
510(k) K964875
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964875 | Date18 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GQH
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3175
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CMV Antigen Control Slides are a type of Antigen, Cf (Including Cf Control), Cytomegalovirus as classified under FDA product code GQH. These slides serve as reference controls in serological tests to detect cytomegalovirus (CMV) antibodies in serum samples, aiding in the diagnosis of CMV-related diseases such as cytomegalic inclusion disease. They provide essential calibration for laboratory testing to ensure accurate interpretation of test results.
These slides are intended for use in microbiology laboratories and are supplied as single-use diagnostic reagents. They are regulated under FDA 510(k) clearance (K964875) and fall under Class II medical devices (device class 2). No information regarding sterility or MRI safety is provided in the specifications. Storage conditions and additional regulatory details are not specified beyond the FDA clearance and product code classification.
Other devices from Viral Antigens, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are CMV Antigen Control Slides used for?
These slides serve as reference controls in serological tests to detect cytomegalovirus (CMV) antibodies in serum samples. They help ensure accurate calibration and interpretation of test results, which is critical for diagnosing CMV-related conditions such as cytomegalic inclusion disease. By providing a standardized control, they help laboratories maintain consistency and reliability in their diagnostic processes.
Are the CMV Antigen Control Slides single-use or reusable?
The CMV Antigen Control Slides are designed for single-use as diagnostic reagents. This classification is standard for control materials in serological testing to prevent cross-contamination between samples and ensure the integrity of test results. Single-use also aligns with best practices for maintaining sterility and accuracy in laboratory settings.
What is the intended use environment for these slides?
These slides are specifically intended for use in microbiology laboratories. They are engineered to support serological testing procedures where precise detection of CMV antibodies is required. The controlled environment of a microbiology lab ensures proper handling, storage, and testing conditions, which are essential for the accuracy of the diagnostic process.
How are the CMV Antigen Control Slides supplied?
The CMV Antigen Control Slides are supplied as individual diagnostic reagents, ready for immediate use in laboratory testing. They are not packaged in bulk or multi-use formats, which helps maintain their stability and effectiveness. This single-use format is typical for control materials in serological assays to avoid degradation or contamination over time.
What regulatory pathway does this device follow?
The CMV Antigen Control Slides are classified under FDA product code GQH and fall under the category of Antigen, Cf (Including Cf Control), Cytomegalovirus. They have received FDA 510(k) clearance (K964875) and are classified as Class II medical devices. This regulatory pathway ensures that the device meets established performance standards and safety requirements for use in diagnostic testing.