FDA Registration
Active
🇦🇹 Austria
TECAN AUSTRIA GMBH
Reg #: 3002710220
·
FEI: 3002710220
·
Expires 2026
Products
6
Proprietary Names
49
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- TECAN AUSTRIA GMBH
- Registration Number
- 3002710220
- FEI Number
- 3002710220
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1A UNTERSBERGSTRASSE
- City
- GROEDIG Salzburg
- Country
- AT
Owner / Operator
- Firm Name
- Tecan Group AG
- Operator Number
- 9050992
- Address
- 103 Seestrasse, --
- City
- Maennedorf
- State
- Zurich
- Postal Code
- 8708
- Country
- CH
US Agent
- Business Name
- Tecan U.S.
- Contact Name
- Taunya Alexander
- Address
- 9401 Globe Center Dr Ste 140
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 919 5725421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2005-02-23 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2002-04-30 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2005-02-23 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2005-02-23 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2007-12-21 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2012-12-05 |
Proprietary Names
HYDROFLEX PLUS
HYDROFLEX
HYDROFLEX EVOLYZER 8CH
HYDROFLEX EVOLYZER 16CH
HYDROFLEX ELISA
HYDROSPEED
HYDROFLEX FREEDOM EVO
96PW
PW384
COLUMBUS
INFINITE F500
INFINITE M1000
INFINITE 200 PRO - INFINITE F Plex
INFINITE 200 PRO - INFINITE Lumi
INFINITE 200 PRO - INFINITE M Nano
INFINITE 200 PRO - INFINITE M Nano+
INFINITE 200 PRO - INFINITE M Plex
INFINITE 200 PRO - INFINITE F Nano+
INFINITE M1000 PRO
INFINITE 200 PRO
INFINITE 200
INFINITE F200 MICROPLATE FLUORESCENCE READER
Magellan Pro
Magellan Basic
Magellan Pro Standard
Magellan Pro Tracker
Magellan Tracker
Magellan Standard
PROFI BLOT 48-2in1
PROFI BLOT T48
PROFI BLOT 48
INFINITE F50 PLUS
INFINITE F50 ROBOTIC
INFINITE F50
SUNRISE
SUNRISE-RC/6F ENFER
SUNRISE-RC/ST TC CRE
SUNRISE-RC/TW EVOLYZER
SUNRISE-RC/ST GL.ABBOTT
INFINITE F50 ROBOTIC FS
SUNRISE-RC/6F EVOLYZER
SUNRISE-RC/ST RMP
SUNRISE-RC/ST EVOLYZER
SUNRISE BF
SUNRISE-RC/ST GENALYSER
SUNRISE-RC/ST ML
PR4100
SUNRISE BF V2
AUTOREADER IV
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)