Panels › Clinical Toxicology › Product code NRP · Class 2
Sirolimus Test System
Regulation 862.3840
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in NRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 2 | 3 |
| Abbott Laboratories | 0 | 2 |
| Abbott Laboratories MPG | 0 | 1 |
| Axis-Shield , Ltd. | 1 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Microgenics Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Sirolimus (SIRO) Flex reagent cartridge Terminated |
NRP | K081857 |
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
NRP | K083487 |
| Feb 9, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability
The SIRO method is an in vitro diagnostic test for the quantitative Terminated |
NRP | K081857 |
| Aug 3, 2010 | Abbott Laboratories Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bot Terminated |
NRP | K070822 |
| Aug 3, 2010 | Abbott Laboratories IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4 Terminated |
NRP | K042411 |
| Feb 15, 2007 | Abbott Laboratories MPG IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bo Terminated |
NRP | K042411 |
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