DYNEX TECHNOLOGIES, INC.

Address:14340 Sullyfield Cir,CHANTILLY,VA,20151,US

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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

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (5) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (5) Station, Pipetting And Diluting, For Clinical Use (JQW) (5)

Premarket Exempt

Yes

Clear

DYNEX DS2 - 05060456180003 Catalog Number : 62010

Device Description : DS2 Automated ELISA Processing System, with Barcode Scanner

Device Class :

Duns Number: 170119536

Premarket Exempt : Yes

Product Code : LXG, JJQ, JQW

Prescription Use : No

Device Count : 1

DYNEX Agility - 05060456180058 Catalog Number : 67000

Device Description : Automated ELISA Processing System with 12 Incubators

Device Class : 1

Duns Number: 170119536

Premarket Exempt : Yes

Product Code : LXG, JJQ, JQW

Prescription Use : No

Device Count : 1

DYNEX DSX - 05060456180287 Catalog Number : 65100

Device Description : Automated ELISA Processing System with 0 Incubators

Device Class : 1

Duns Number: 170119536

Premarket Exempt : Yes

Product Code : LXG, JJQ, JQW

Prescription Use : No

Device Count : 1

DYNEX DS2 - 05060456180317 Catalog Number : 62000

Device Description : DS2 Automated ELISA Processing System

Device Class : 1

Duns Number: 170119536

Premarket Exempt : Yes

Product Code : LXG, JJQ, JQW

Prescription Use : No

Device Count : 1

DIALISA 2MP - 05060456180348 Catalog Number : 62003

Device Description : DIALISA 2MP, DS2 Automated ELISA Processing System

Device Class : 1

Duns Number: 170119536

Premarket Exempt : Yes

Product Code : LXG, JJQ, JQW

Prescription Use : No

Device Count : 1

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