Latex Agglutination Assay, Rubella
The Rubella Latex Agglutination Assay is an in vitro diagnostic device that uses latex particle agglutination methodology to detect rubella virus antibodies in patient serum, used to determine immune status or diagnose acute rubella infection. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQN, regulated under 21 CFR 866.3510, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LQN
- Device Class
- FDA class 2
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031490 | RUBELLACOL | Jul 16, 2003 | Substantially Equivalent | Immunostics Inc., |
| K970931 | COPALIS TORC TOTAL ANTIBODY ASSAY | Apr 24, 1997 | Substantially Equivalent | Sienna Biotech, Inc. |
| K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS | Oct 31, 1996 | Substantially Equivalent | Sienna Biotech, Inc. |
| K954920 | MUREX RUB-EX | Aug 21, 1996 | Substantially Equivalent | Murex Diagnostics, Inc. |
| K952544 | COLORSLIDER RUBELLA | Jan 17, 1996 | Substantially Equivalent | Seradyn, Inc. |
| K912391 | RUBALEX, MODIFICATION | May 04, 1992 | Substantially Equivalent | Orion Corp. |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Apr 26, 1990 | Substantially Equivalent | Orion Corp. |
| K896433 | MODIFIED RUBAGEN | Nov 29, 1989 | Substantially Equivalent | Biokit USA, Inc. |
| K893755 | RUBAGEN | Aug 21, 1989 | Substantially Equivalent | Biokit USA, Inc. |
| K861881 | RUBALEX (REVISED VERSION) | Jun 04, 1986 | Substantially Equivalent | Orion Corp. |
| K852788 | RUBALEX | Mar 12, 1986 | Substantially Equivalent | Orion Corp. |
| K844436 | VIROGEN RUBELLA MICROTITER TEST | May 21, 1985 | Substantially Equivalent | Armkel, LLC |
| K844435 | VIROGEN RUBELLA SLIDE TEST | May 20, 1985 | Substantially Equivalent | Armkel, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.