Panels › Clinical Chemistry › Product code MLM · Class 2
Enzyme Immunoassay, Tracrolimus
Regulation 862.1678
0510(k)s in 12 months (9 all time)
1recalls in 12 months (13 all time)
8recalls that name a 510(k)
Top companies in MLM
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 7 |
| Microgenics Corp. | 2 | 1 |
| Abbott Laboratories HPD/ADD/GPRD | 0 | 2 |
| Dade Behring, Inc. | 2 | 0 |
| Diasorin Inc. | 0 | 2 |
| Abbott Laboratories | 0 | 1 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Shanghai Genext Medical Technology Co., Ltd. | 1 | 0 |
| Waters Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2026 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay Open, Classified |
MLM | K150168 |
| Mar 15, 2023 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system
SMN: 10700795 Open, Classified |
MLM | K150168 |
| Jan 20, 2022 | Microgenics Corporation QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET
QMS TACROLIMUS CAL A 10015566-3
QMS TACROLIMUS CAL B 10015567-3
QMS TACROLIMUS CAL C 10015568-3
QMS TACROLIMUS CAL D 10015569-3
QMS TACROLIMUS C Open, Classified |
MLM | K123343 |
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
MLM | K060385 |
| Apr 20, 2015 | Diasorin Inc. DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN.
Product Usage:
The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tac Terminated |
MLM | None listed |
| Dec 16, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) TACR Flex(R) reagent cartridge (DF107)
The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chem Terminated |
MLM | None listed |
| Aug 7, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)
Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in huma Terminated |
MLM | K060502 |
| Mar 15, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. Terminated |
MLM | K060502 |
| Oct 15, 2010 | Abbott Laboratories Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, A Terminated |
MLM | K070820 |
| Sep 13, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware. Terminated |
MLM | K060502 |
| Apr 13, 2005 | Diasorin Inc. Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit Terminated |
MLM | None listed |
| Dec 17, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MLM | None listed |
| Oct 24, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng Terminated |
MLM | None listed |
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