Access Rubella Igg
by Bio-Rad Laboratories, Inc. 510(k)
Active
510(k) K954687
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954687 | Date9 Apr 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3510
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Bio-Rad offers the Rubella IgG EIA assay for the qualitative, semi-quantitative, and quantitative detection of rubella IgG antibodies and the Rubella IgM EIA assay for the qualitative detection of rubella IgM antibodies in human serum. The IgG test is used as an aid in assessing patient immunological status to rubella.
Description Bio-Rad offers the Rubella IgG EIA assay for the qualitative, semi-quantitative, and quantitative detection of rubella IgG antibodies and the Rubella IgM EIA assay for the qualitative detection of rubella IgM antibodies in human serum or plasma. The IgG test is used as an aid in assessing patient immunological status to rubella.