tecan.comGENESIS RMP
TECAN U.S., INC.
TECAN U.S.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1037985 | 1037985 | TECAN U.S. | 1 | Y | 2026-01-01 | 9401 Globe Center Dr Ste 140 Morrisville NC US 27560 |
| 3002710220 | 3002710220 | TECAN AUSTRIA GMBH | 1 | N | 2026-01-01 | 1A UNTERSBERGSTRASSE GROEDIG Salzburg AT 5082 |
| 3003537036 | 3003537036 | TECAN CDMO SOLUTIONS MH, CORP. | 1 | N | 2026-01-01 | 18735 MADRONE PKWY. MORGAN HILL CA US 95037 |
| 3010848378 | 3010848378 | TECAN Trading AG-Central Warehouse Americas | 1 | Y | 2026-01-01 | Crane Worldwide Logistics 4615 Entrance Drive, Suite A Charlotte NC US 28273 |
| 2916719 | 2916719 | TECAN SYSTEMS INC | 1 | N | 2020-04-25 | 2450 Zanker Rd SAN JOSE CA US 95131 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07640137480288 | Veya Dx 6 - configurable liquid handling workstation | +41449228282 | helpdesk-ch@tecan.com |
| 07640137480295 | Veya Dx 9 - configurable liquid handling workstation | +41449228282 | helpdesk-ch@tecan.com |
| 09120052070880 | MAGELLAN PRO - Reader control and data reduction software for Tecan Microplate Reader. | +18003525128 | helpdesk-us@tecan.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20821 | 1686580788 | K131301 | BD FACS SAMPLE PREP ASSISTANT III | PER | 2013-08-02 |
| 20821 | 1368883614 | K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | PER | 2013-07-15 |
| 20821 | 1967781753 | K102064 | BD FACS SAMPLE PREP ASSISTANT III (SPA III) | GKZ | 2011-03-07 |
| 20821 | 2027889569 | ||||
| 20820 | 1067120366 | ||||
| 20820 | 1113815507 | ||||
| 296908 | 1116716678 | ||||
| 296908 | 1135426531 | ||||
| 296908 | 1338868860 | ||||
| 296908 | 1368883614 | ||||
| 296908 | 1404248591 | ||||
| 296908 | 1466487885 | ||||
| 296908 | 1603768941 | ||||
| 296908 | 1603903683 | ||||
| 296908 | 1609201540 | ||||
| 20820 | 1648870765 | ||||
| 296908 | 1686580788 | ||||
| 20820 | 1691019270 | ||||
| 20820 | 1800906875 | ||||
| 20820 | 1895041127 | ||||
| 296908 | 1923812079 | ||||
| 296908 | 1999481426 | ||||
| 296908 | 2023481367 | ||||
| 296908 | 2027889569 |
Product Codes Associated With Registrations#
PMN#
EEG ELECTRODES
TECA, INC.
GENESIS
TECAN U.S., INC.
4 CHANNEL DISPENSER
TECAN U.S., INC.
4 CHANNEL DISPENSER
TECAN U.S., INC.
PROFIBLOT
TECAN U.S., LTD.
RSP MEGA SAMPLE PROCESSOR
TECAN U.S., LTD.
ROBOTIC SAMPLE PROCESSOR
TECAN U.S., LTD.
SLT MICROPLATE WASHER
TECAN U.S., LTD.
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
TECA, INC.
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
TECA, INC.
P460, DG32 ELECTROENCEPHALOGRAPH
TECA, INC.
TECA NEUROMAPPER 386
TECA, INC.
TECA NEUROMAPPER 1620, BRAIN MAPPER
TECA, INC.
ROBOTIC SAMPLE PROCESSOR
TECAN U.S., LTD.
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
TECA, INC.
TECA/MEDELEC 'CONCEPT' P420
TECA, INC.
TECA/MEDELEC MISTRAL
TECA, INC.
TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
TECA, INC.
TECA/MEDELEC AS-10 SENSOR
TECA, INC.
TECA/MEDELEC AUDIOSTAR
TECA, INC.
TECA NEUROPTO WITH OS-5 STIMULATOR
TECA, INC.
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
TECA, INC.
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
TECAN U.S., LTD.
TECA TC2-64 TRANSCRANIAL DOPPLER
TECA, INC.
TECA MONTAGE II
TECA, INC.
NEUROLAB II
TECA, INC.
TECA MF-20 MICROVASCULAR DOPPLER
TECA, INC.
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
TECA, INC.
LED STIMULATOR LS-05
TECA, INC.
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
TECA, INC.
TECA MODEL SENSOR ER 94
TECA, INC.
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
TECA, INC.
TECA #TE 8
TECA, INC.
TECA MODEL-10 ELECTROMYOGRAPH
TECA, INC.
TECA MODEL B9 ELECTROMYOGRAPH
TECA, INC.
TECA VS6 VIDEO STIMULATOR
TECA, INC.
GUDID#
MAGELLAN - Reader control and data reduction software for Tecan Microplate Reader.
2020-12-01
MAGELLAN - Reader control and data reduction software for Tecan Microplate Reader.
2020-12-01
MAGELLAN PRO - Reader control and data reduction software for Tecan Microplate Reader.
2020-01-07
MAGELLAN PRO - Reader control and data reduction software for Tecan Microplate Reader.
2020-01-07
Veya Dx 9 - configurable liquid handling workstation
2025-03-31
Veya Dx 6 - configurable liquid handling workstation
2025-03-31
USB-STICK MAGELLAN PRO V7.5 - This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x
2023-02-26
USB-STICK MAGELLAN V 7.5 - This media contains V 7.5 of the following registered Medical Devices:(DI)09120052070996 (SOFTWARE MAGELLAN V 7.X),(DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
2023-07-07
USB-STICK MAGELLAN V 7.5 SUNRISE+F50 - This media contains V 7.5 of the following registered Medical Devices:(DI)09120052070996 (SOFTWARE MAGELLAN V 7.X),(DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
2022-05-26
Fluent® - configurable liquid handling workstation
2020-11-16
Fluent® - configurable liquid handling workstation
2020-11-16
Fluent® - configurable liquid handling workstation
2020-11-16
SUNRISE-RC/6F EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2023-07-06
SUNRISE-RC/TW EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2023-07-06
SUNRISE-RC/ST EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2023-07-06
SUNRISE - microplate reader
2023-07-06
USB-STICK MAGELLAN PRO V7.5 - This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x
2023-02-26
USB-STICK MAGELLAN PRO V7.4 - This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
2022-08-17
Infinite F50 ROBOTIC FS - The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.It is intended to be integrated in robotic solutions.
2020-07-12
Infinite F50 ROBOTIC - The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.It is intended to be integrated in robotic solutions.
2020-07-12
Infinite F50 - The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.
2020-07-12
Infinite F50 - The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.
2020-07-12
Infinite F50 - The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.
2020-07-12
HYDROSPEED - Microplate washer
2020-09-04
SUNRISE - microplate reader
2020-09-04
HYDROFLEX - Microplate washer
2020-09-17
SUNRISE-RC/6F EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2020-12-01
SUNRISE-RC/TW EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2020-12-01
SUNRISE-RC/ST EVOLYZER - microplate reader - intended to be integrated in robotic solutions
2020-12-01
HYDROFLEX FOR FREEDOM EVO - Microplate washer
2020-09-18
HYDROFLEX EVOLYZER 16CH - Microplate washer
2020-09-18
HYDROFLEX EVOLYZER 8CH - Microplate Washer
2020-09-18
HYDROFLEX ELISA - Microplate washer
2020-09-18
INFINITE 200 PRO - microplate reader
2021-06-22
Hydroflex Plus - Microplate washer
2022-05-26
Infinite F50 Plus - The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis software.
2022-05-26
USB-STICK MAGELLAN PRO V7.4 - This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
2021-01-07
USB-STICK MAGELLAN PRO V 7.5 - This media contains V 7.3 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
2022-05-26
USB-STICK MAGELLAN 7.3 SP2 - This media contains the following registered Medical Devices:(DI) 09120052070996 MAGELLAN V7.X(DI) 09120052071009 MAGELLAN TRACKER V7.X
2020-12-01
USB-STICK MAGELLAN PRO V 7.3 - This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
2020-01-07