TREK DIAGNOSTIC SYSTEMS LIMITED

Address:Units 17 - 19,East Grinstead West Sussex,GB

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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

Manual Antimicrobial Susceptibility Test Systems (JWY) (5) Susceptibility Test Plate, Antifungal (NGZ) (2) Gram Negative Identification Panel (LQM) (1) Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (LRG) (1)

Premarket Exempt

No Yes

Clear

Sensititre - M578GPALL2F2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

Sensititre - M578GPALL3F2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

Sensititre - M578GPID2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : Yes

Product Code : LQM

Prescription Use : No

Device Count : 10

Sensititre - M578GPN3F2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

Sensititre - M578NF2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

Sensititre - M578STP6F2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST - M578V4000 Catalog Number :

Device Description : The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incu The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument.

Device Class : 2

Duns Number: 298203498

Premarket Exempt : No

Product Code : LRG

Prescription Use : Yes

Device Count : 1

Sensititre - M578YO2IVD2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : NGZ

Prescription Use : No

Device Count : 10

Sensititre - M578YO3IVD2 Catalog Number :

Device Class :

Duns Number: 298203498

Premarket Exempt : No

Product Code : NGZ

Prescription Use : No

Device Count : 10

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