Product code LQN
- Device name
- Latex Agglutination Assay, Rubella
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3510
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031490 | RUBELLACOL | Immunostics Inc., | 2003-07-16 |
| K970931 | COPALIS TORC TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | 1997-04-24 |
| K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS | Sienna Biotech, Inc. | 1996-10-31 |
| K954920 | MUREX RUB-EX | Murex Diagnostics, Inc. | 1996-08-21 |
| K952544 | COLORSLIDER RUBELLA | Seradyn, Inc. | 1996-01-17 |
| K912391 | RUBALEX, MODIFICATION | Orion Corp. | 1992-05-04 |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Orion Corp. | 1990-04-26 |
| K896433 | MODIFIED RUBAGEN | Biokit USA, Inc. | 1989-11-29 |
| K893755 | RUBAGEN | Biokit USA, Inc. | 1989-08-21 |
| K861881 | RUBALEX (REVISED VERSION) | Orion Corp. | 1986-06-04 |
| K852788 | RUBALEX | Orion Corp. | 1986-03-12 |
| K844436 | VIROGEN RUBELLA MICROTITER TEST | Armkel, LLC | 1985-05-21 |
| K844435 | VIROGEN RUBELLA SLIDE TEST | Armkel, LLC | 1985-05-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00006136471226 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471233 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471240 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471219 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00613647001240 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 00613647001233 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 00613647001226 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 00613647001219 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 08426950590583 | Rubajet 500 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 08426950590576 | Rubajet 100 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 08426950590569 | Rubagen 100 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 20885380020190 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380020206 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380020183 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 00816057020423 | ASI Rubella Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020430 | ASI Rubella Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020447 | ASI Rubella Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020454 | ASI Rubella Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057021635 | ASI Rubella Test Control Set | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |