Product code MKW
- Device name
- Cyclosporine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1235
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P920031S003 | COBAS INTEGRA 400 PLUS CYCLOSPORINE | Dade Behring, Inc. | 2002-07-24 |
| P920031S002 | COBAS INTEGRA CYCLOSPORINE | Dade Behring, Inc. | 2002-02-26 |
| P920031S001 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 2000-08-11 |
| P920031 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 1996-10-02 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-08-21 |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 2006-02-06 |
| K052017 | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 | Dade Behring, Inc. | 2005-09-01 |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | 2004-04-30 |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | 2002-10-24 |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2002-10-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00869164000079 | Emit Cyclosporine Sample | FUJIREBIO DIAGNOSTICS, INC. | 2023-12-06 |
| 00380740168209 | Alinity-Architect | ABBOTT LABORATORIES | 2019-06-14 |
| 00630414598765 | Atellica IM CsA PRE Pretreatment | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598741 | Atellica IM Multi-Diluent 12 | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598727 | Atellica IM CsA | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00884883011861 | CEDIA Cyclosporine-PLUS Assay | Microgenics Corporation | 2016-09-24 |
| 00842768001451 | Syva® Emit® 2000 Cyclosporine Specific Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001468 | Syva® Emit® 2000 Cyclosporine Specific Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001475 | Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001482 | Syva® Emit® Cyclosporine Pretreatment Reagent | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005268 | Dimension® Flex® reagent cartridge CSAE | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015144 | Dimension Vista® Flex® reagent cartridge CSA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768016035 | Dimension Vista® Flex® reagent cartridge CSAE | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768025136 | Dimension® CSA Flex® reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414524450 | ADVIA Centaur® CsA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414524474 | ADVIA Centaur® CsA PRE Pretreatment | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414525549 | ADVIA Centaur® Multi-Diluent 12 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630997459 | CSAII Cyclosporine II | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883001589 | CEDIA Cyclosporine PLUS Assay | Microgenics Corporation | 2016-09-12 |
| 00380740081911 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740001322 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001308 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001315 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |