Cmv Igm Elisa Test
by Gull Laboratories, Inc. 510(k)
Active
510(k) K903807
Overview
The CMV IgM ELISA Test is an enzyme-linked immunosorbent assay used to detect cytomegalovirus antibodies in patient samples. This laboratory test is designed to identify IgM antibodies specific to cytomegalovirus, which can indicate recent or active infection. The test is categorized under the microbiology specialty and operates as a Class II medical device.
This test is supplied as a laboratory diagnostic kit and is intended for single-use in clinical laboratory settings. The device is FDA 510(k) cleared with K number K903807 and is manufactured by Gull Laboratories, Inc. in Salt Lake City, Utah. The test is stored according to manufacturer specifications and requires appropriate laboratory equipment and trained personnel for proper execution.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903807 | Date17 Dec 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3175
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Gull Laboratories, Inc.
Questions
What is the CMV IgM ELISA Test used for?
The CMV IgM ELISA Test is a laboratory diagnostic kit used to detect IgM antibodies specific to cytomegalovirus in patient samples, which can indicate recent or active infection. It is designed for clinical laboratory settings and operates as a Class II medical device.
How is the CMV IgM ELISA Test supplied and is it single-use?
The test is supplied as a laboratory diagnostic kit and is intended for single-use in clinical laboratory settings. It requires appropriate laboratory equipment and trained personnel for proper execution according to manufacturer specifications.
What is the regulatory status of the CMV IgM ELISA Test?
The CMV IgM ELISA Test is FDA 510(k) cleared with K number K903807 and is categorized under the microbiology specialty. It is manufactured by Gull Laboratories, Inc. in Salt Lake City, Utah, and is stored according to manufacturer specifications.
What equipment and personnel are required to perform the CMV IgM ELISA Test?
The CMV IgM ELISA Test requires appropriate laboratory equipment and trained personnel for proper execution. It is designed for clinical laboratory settings where the necessary infrastructure and expertise are available to perform the enzyme-linked immunosorbent assay accurately.