Axsym Rubella Igg Antibody Assay
FDA 510(k) K954045 · Abbott Laboratories
510(k) numberK954045
Submission
- Device name
- Axsym Rubella Igg Antibody Assay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 29, 1995
- Decision date
- September 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
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| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was Axsym Rubella Igg Antibody Assay cleared by the FDA?
Axsym Rubella Igg Antibody Assay (K954045) received a 510(k) decision of Substantially Equivalent on September 24, 1996, 392 days after the submission was received.
What is the product code of K954045?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.