Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

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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

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (7) Counter, Differential Cell (GKZ) (1) Electrode, Ion Specific, Potassium (CEM) (1) Electrode, Ion Specific, Sodium (JGS) (1)

Premarket Exempt

Clear

Pictus 700 clinilcal chemistry analyzer - 05999860094180 Catalog Number : P700-3

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Pictus 500 Clinical chemistry analyzer - 05999860094197 Catalog Number : P500-1-o

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Pictus 500 Clinical chemistry analyzer - 05999860094203 Catalog Number : P500-2

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Pictus 500 Clinical chemistry analyzer - 05999860094210 Catalog Number : P500-2-o

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Pictus 400 Clinical chemistry analyzer - 05999860094227 Catalog Number : P400-3

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Pictus 400 Clinical chemistry analyzer - 05999860094234 Catalog Number : P400-4

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Abacus 5 Hematology Analyzer - 05999883586228 Catalog Number : A5US-1

Device Description : Abacus 5 is an automated differential cell counter device used to identify one o

Device Class :

Duns Number: 427395277

Premarket Exempt : No

Product Code : GKZ

Prescription Use : No

Device Count : 1

Pictus 500 Clinical chemistry analyzer - 05999883586679 Catalog Number : P500-1

Device Description : A discrete photometric chemistry analyzer for clinical use is a device intended

Device Class : 1

Duns Number: 427395277

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

NA ELECTRODE, ISE MODULE - 05999883586686 Catalog Number : 5201

Device Description : Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a

Device Class : 2

Duns Number: 427395277

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

K ELECTRODE, ISE MODULE - 05999883586693 Catalog Number : 5202

Device Description : Clinical Chemistry Test Systems / Potassium test system. A potassium test syste

Device Class :

Duns Number: 427395277

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

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