This page includes the latest FDA filings for Michael Leslie. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013496958 |
| FEI Number | 3013496958 |
| Name | Michael Leslie |
| Owner & Operator | Produkt Service Erdt GmbH |
| Contact Address | Max-Planck-Strasse 36a Viernheim DE-HE Hessen 68519 DE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 9115 Hague Road Castleton, IN 46250 US |
| Establishment Type | Repack or Relabel Medical Device |
| Registration Number | 3014505168 |
| FEI Number | 3014505168 |
| Name | Michael Leslie |
| Owner & Operator | Novoplast AG |
| Contact Address | Rheinstrasse 74 Wallbach CH-AG Aargau 4323 CH |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 9115 Hague Rd Indianapolis, IN 46250 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3010900203 |
| FEI Number | 3010900203 |
| Name | Michael Leslie |
| Owner & Operator | Roche Diagnostics Operations Inc. |
| Contact Address | 9115 Hague Road Indianapolis IN 46250 US |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 9115 Hague Road Indianapolis, IN 46250 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
Michael Leslie [Novoplast AG] | MagNA Pure 96 Waste Rack IVD | 2019-01-14 |
Michael Leslie [Novoplast AG] | MagNA Pure 96 Reagent Rack IVD | 2019-01-14 |
Michael Leslie [Novoplast AG] | MagNA Pure 96 Purification Rack IVD | 2019-01-14 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 96 External Lysis Buffer | 2018-02-02 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 96 DNA and Viral NA SV Kit | 2018-02-02 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 96 DNA and Viral NA LV Kit | 2018-02-02 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 96 DNA Tissue Lysis Buffer | 2018-02-02 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 96 Bacterial Lysis Buffer | 2018-02-02 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC Total Nucleic Acid Isolation Kit-High Perf | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC Total Nucelid Acid Isolation Kit | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC Total Nucelid Acid Isolation Kit LV | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC TNA Kit I Lysis | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC RNA Kit III | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC RNA KIT HP | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC DNA KIT I | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure LC DNA ISO KIT-LG VOL | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA Pure 24 Total NA Isolation Kit | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MagNA PURE DNA TISSUE LYSIS BUFFER | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MPLC Total Nucleic Acid Isolation KIt | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MPLC DNA Isol. Kit II [Tissue] | 2016-07-12 |
Michael Leslie [Produkt Service Erdt GmbH] | MAGNA PURE COMPACT RNA ISO KIT | 2016-07-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | turn unit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | p501/p701 Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | output unit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | conveyor unit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas8800B | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p701 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p671 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p501/p701 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p471 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 612 system | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 612 pre-analytical system | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 512 pre-analytical system | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 512 System Software | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 501/701 System Software | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas p 501/ p 701 system software | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity sw v3.01.07 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity sw v2.5.3 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity insights license | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity core license | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas infinity POC IT solutions | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas connection module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas bge link | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.3.3 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.3.2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.2.3 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.2.2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity v2.2.1 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity sw v2.5.1 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Infinity 3rd Party Drivers | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas IT 1000 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas IT 1000 i-STAT/DE module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas IT 1000 Operator Sync | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas Academy | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 connection kit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 URF . | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 Signal Tower | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 RSS | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 RSF | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 OBS | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 Model Alpha | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 BCL | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 BCL - FBT Modification kit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 AOB | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | cobas 8100 ACU | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | centrifuge unit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 Wright Patterson Air Force Base US | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 Type Alpha | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 TLJ | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 SW 03-09 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 SLR | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 SLL | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 SCM | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 RFX | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 PXT | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 Model Beta | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 CRW | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 CRO | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 CLW | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 CLO | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 Beta | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 BRF | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | c8100 BCL | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Vantage | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | VS Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | VANTAGE 2.5.2 Software Installer | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Universal Connection Unit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Sorting System cobas p312(Kolibri) | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | SW PATCH_P312_1.1.3_UPD.TAR.BZ2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | SW COBAS P 312 VERSION 1.1.1 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P671 TTI W/O BC READ UN 115V | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P671 TTI BC READING UN 115V | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P612 LASER LLD QSI REC w/o CCM | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P612 LASER LLD QSI 3HHT CCM | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P471 TTI W/O BC READ UN 115 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | STD INSTR P471 TTI BC READING UNIT 115V | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Roche cobas Liat Module- IT 1000 Bi-directional driver | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | RSD Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | RSA Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Piccolo Xpress module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | PComm ver. 1.12.12 with script_1.12.13 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | PComm ver 1.12.11 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Online Adapter 1.5.0.0 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | MPA Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | MPA EVO Analycer connection | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Liquid Level Detection UPGR Kit | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Laser LLD | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | LASER LLD INCL QSI/TTI | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | IT 1000- PCOmmunicator .bat file | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | IT 1000 Operator Data driver ver. 1.1.2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | IT 1000 All in one installer | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Host CIT1k 3.0.9 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | HemoCue 201DM Hb module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | HemoCue 201DM Glu module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | HemoCue 201DM Glu RT module | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Driver Framework 3.1.0.8915 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Data Innovations Instrument Manager | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Comm Server 1.11.0.3725 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Coaguchek Link | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CoaguChek Link Tier 3 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CoaguChek Link Tier 2 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CoaguChek Link Tier 1 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CLAS Systems | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CCM AOB sw ver 1.03 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Bulk Loader for cobas p 471 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Bulk Loader Module for p512/612 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | BCM for cobas 8100 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | Aliquot Tip Loader | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | 770-1-CCM-AOB v1.1.0 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | 713-2-cobase 8100 v1.0.5 | 2008-06-12 |
Michael Leslie [Roche Diagnostics Operations Inc.] | 579-2-RSA Dynamic Interface v1.1.0 | 2008-06-12 |