PHOENIX DIAGNOSTICS, INC.

Address:8 TECH CIRCLE,Natick,MA,01760,US

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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

Electrode, Ion Specific, Potassium (CEM) (4) Electrode, Ion Specific, Sodium (JGS) (4) Electrode, Ion-Specific, Chloride (CGZ) (3) Calibrator, Multi-Analyte Mixture (JIX) (2) Detergent (JCB) (1) Electrode, Ion Selective (Non-Specified) (JJP) (1)

Premarket Exempt

Yes No

Clear

Phoenix Diagnostics - 00853366007042 Catalog Number :

Device Description : ISE Low Serum Standard for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Phoenix Diagnostics - 00853366007059 Catalog Number : 21-105

Device Description : ISE High Serum Standard for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007066 Catalog Number :

Device Description : ISE Low/High Urine Standard for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007073 Catalog Number :

Device Description : ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007080 Catalog Number :

Device Description : ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JGS, CEM

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007097 Catalog Number :

Device Description : Cleaning Solution for Olympus AU Series Chemistry Systems

Device Class : 1

Duns Number: 606814960

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007103 Catalog Number :

Device Description : Na+ Electrode for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007110 Catalog Number :

Device Description : K+ Electrode for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007127 Catalog Number :

Device Description : Cl- Electrode for Olympus AU Series Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : CGZ

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007134 Catalog Number :

Device Description : Reference Electrode for Olympus AU Series Chemistry Systems

Device Class : 1

Duns Number: 606814960

Premarket Exempt : No

Product Code : JJP

Prescription Use : No

Device Count : 1

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