Product code MLM
- Device name
- Enzyme Immunoassay, Tracrolimus
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1678
- 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 |
|---|---|---|---|
| P970007S004 | IMX TACROLIMUS II | Abbott Laboratories | 2002-09-05 |
| P970007S003 | IMX TACROLIMUS II | Abbott Laboratories | 2002-09-05 |
| P970007S002 | IMX TACROLIMUS II | Abbott Laboratories | 2001-03-30 |
| P970007S001 | ABBOTT IMX TACROLIMUS II | Abbott Laboratories | 1999-09-22 |
| P970025 | PRO-TRAC II TACROLIMUS ELISA KIT | DiaSorin, Inc. | 1999-04-27 |
| P970007 | IMX TACROLIMUS II ASSAY | Abbott Laboratories | 1997-08-26 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203833 | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
| K173857 | Elecsys Tacrolimus | Roche Diagnostics | 2018-11-06 |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics | 2015-11-04 |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Microgenics Corp. | 2013-07-11 |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | 2007-08-01 |
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | Waters Corporation | 2007-05-25 |
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | Dade Behring, Inc. | 2006-05-18 |
| K060385 | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | Dade Behring, Inc. | 2006-04-06 |
| K050206 | CEDIA TACROLIMUS ASSAY | Microgenics Corp. | 2005-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740154240 | Alinity | Abbott Ireland Diagnostics | 2020-01-02 |
| 00380740154516 | Alinity | Abbott Ireland Diagnostics | 2020-01-02 |
| 00380740168209 | Alinity-Architect | ABBOTT LABORATORIES | 2019-06-14 |
| 04015630940271 | Elecsys Tacrolimus | Roche Diagnostics GmbH | 2019-02-14 |
| 04015630947102 | Elecsys Tacrolimus | Roche Diagnostics GmbH | 2019-01-14 |
| 00630414238340 | Atellica CH TACR | Siemens Healthcare Diagnostics Inc. | 2018-10-08 |
| 00842768030048 | Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001666 | Syva® Emit® 2000 Tacrolimus Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768018312 | Dimension® Flex® reagent cartridge TACR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768035425 | Dimension® Flex® reagent cartridge TAC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00816776020001 | MassTrak™ | WATERS TECHNOLOGIES CORPORATION | 2016-09-24 |
| 00884883011830 | QMS Tacrolimus Immunoassay | Microgenics Corporation | 2016-09-22 |
| 00380740081911 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740001384 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740001360 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740001377 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |