Rubella Igm Microassay
510(k) K883778
Rubella Igm Microassay is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K883778 on 25 Oct 1988, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883778 | Date25 Oct 1988 | StatusActive |
Official records
- FDA 510(k) database K883778
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Similar devices
Other devices filed under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).
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- Rubella IgM ELISA Test System by ZEUS SCIENTIFIC, INC.
- ACCESS RUBELLA IGG by Bio-Rad Laboratories, Inc.
- Atellica IM Rub G QC 10995671 by Siemens Healthcare Diagnostics Inc.
- TRANSTAT-CMV(TM) by Ab Sangtec Medical
- Immulite Rubella Quantitative IgG, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests) by Diagnostic Products Corp.
- RUBELLA IGG ELISA TEST by Gull Laboratories, Inc.
- RUBELLA IGG by Pharmacia Diagnostics, Inc.