Tecan Austria GmbH

Address:1A UNTERSBERGSTRASSE,GROEDIG Salzburg,AT

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (5) Calculator/Data Processing Module, For Clinical Use (JQP) (2) Slide Stainer, Automated (KPA) (2) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Fluorometer, For Clinical Use (KHO) (1)

Premarket Exempt

Yes

Clear

HYDROFLEX ELISA - 09120052070453 Catalog Number : 30087532

Device Description : Microplate washer

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

HYDROFLEX EVOLYZER 8CH - 09120052070460 Catalog Number : 30087533

Device Description : Microplate Washer

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

HYDROFLEX EVOLYZER 16CH - 09120052070477 Catalog Number : 30087534

Device Description : Microplate washer

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

HYDROFLEX FOR FREEDOM EVO - 09120052070484 Catalog Number : 30087535

Device Description : Microplate washer

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

HYDROSPEED - 09120052070491 Catalog Number : 30087536

Device Description : Microplate washer

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

PROFI BLOT 48 - 09120052070507 Catalog Number : 30087537

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

PROFI BLOT T48 - 09120052070514 Catalog Number : 30087538

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

INFINITE 200 PRO - 09120052070521 Catalog Number : 30050303

Device Description : microplate reader

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : JJQ, KHO

Prescription Use : No

Device Count : 1

MAGELLAN PRO - 09120052070880 Catalog Number :

Device Description : Reader control and data reduction software for Tecan Microplate Reader.

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

MAGELLAN PRO - 09120052070910 Catalog Number :

Device Description : Reader control and data reduction software for Tecan Microplate Reader.

Device Class : 1

Duns Number: 301237509

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

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