JEOL LTD.

Address:3-1-2 Musashino,Akishima Tokyo,JP

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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

Calibrator, Multi-Analyte Mixture (JIX) (3) Electrode, Ion Specific, Potassium (CEM) (1) Electrode, Ion Specific, Sodium (JGS) (1) Electrode, Ion-Specific, Chloride (CGZ) (1)

Premarket Exempt

No Yes

Clear

Chloride Electrode - 04987762129858 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : No

Product Code : CGZ

Prescription Use : No

Device Count : 1

Potassium Electrode - 04987762129865 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

Sodium Electrode - 04987762129872 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

ISE Serum Standard Set NA - 04987762129889 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Internal Standard - 04987762129896 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

ISE Urine Standard Set - 04987762129902 Catalog Number :

Device Class : 2

Duns Number: 690565023

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

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