Enzyme Linked Immunoabsorbent Assay, Rubella
by Pyramid Biological Corp. 510(k)
Active
510(k) K954515
Overview
The Enzyme Linked Immunosorbent Assay, Rubella is a laboratory test device used for the detection of antibodies to the rubella virus. This assay is classified under the medical specialty of microbiology and is designed to identify immune responses specific to rubella infection.
The device is supplied as a single-use test and is regulated under FDA 510(k) clearance with product code GOM. It is stored according to manufacturer specifications and is intended for in vitro diagnostic use. The device has received FDA clearance as substantially equivalent to predicate devices for rubella antibody detection.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954515 | Date20 Dec 1995 | 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- Withdrawn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
- GOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3510
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pyramid Biological Corp.
Questions
What is the purpose of the Rubella ELISA test kit?
The Rubella ELISA test kit is a laboratory device used to detect antibodies to the rubella virus. It helps identify immune responses specific to rubella infection, which is important for diagnosing current or past rubella exposure.
How is the Rubella ELISA test supplied and is it reusable?
The Rubella ELISA test is supplied as a single-use device, meaning it is designed for one testing procedure only. After use, the test should be disposed of according to laboratory protocols and manufacturer instructions.
What are the storage requirements for this test kit?
The Rubella ELISA test kit should be stored according to the manufacturer's specifications, which typically include maintaining it at controlled room temperature or refrigeration conditions as specified in the product instructions. Proper storage ensures test accuracy and reliability.
What regulatory clearance does this test have?
The Rubella ELISA test has received FDA 510(k) clearance with product code GOM. It is classified as substantially equivalent to predicate devices for rubella antibody detection and is intended for in vitro diagnostic use only.