Product code MTF ยท Class 3
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
0510(k)s in 12 months (0 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in MTF
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics Inc. | 0 | 8 |
| BioMerieux SA | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2024 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) Open, Classified |
MTF | None listed |
| Dec 21, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog)
Product Usage:
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers Terminated |
MTF | None listed |
| Dec 21, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog)
Product Usage:
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers Terminated |
MTF | None listed |
| Nov 18, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SM Terminated |
MTF | None listed |
| Nov 18, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS Terminated |
MTF | None listed |
| Feb 4, 2016 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit)
Product Usage:
This in vitro diagnostic assay is intended to qua Terminated |
MTF | None listed |
| Aug 6, 2014 | BioMerieux SA VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. Terminated |
MTF | None listed |
| May 11, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge
Product Usage:
The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific Terminated |
MTF | None listed |
| Jun 28, 2008 | Siemens Healthcare Diagnostics Inc. Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714 Terminated |
MTF | None listed |
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