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

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

Premarket Exempt

No Yes

Clear

Phoenix Diagnostics - 00853366007240 Catalog Number : 16-222

Device Description : Hitergent for Roche / Hitachi 900 Series

Device Class : 1

Duns Number: 606814960

Premarket Exempt : No

Product Code : JCB

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007257 Catalog Number :

Device Description : Cell Clean 90, 1N NaOH for Roche / Hitachi Chemistry Systems

Device Class : 1

Duns Number: 606814960

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007264 Catalog Number :

Device Description : System Cleaning Solution for Roche / Hitachi Chemistry Systems

Device Class : 1

Duns Number: 606814960

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007271 Catalog Number :

Device Description : ISE Compensator for Roche / Hitachi Chemistry Systems

Device Class :

Duns Number: 606814960

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Phoenix Diagnostics - 00853366007288 Catalog Number : 16-218

Device Description : K Calibrator for Roche / Hitachi Chemistry Systems

Device Class :

Duns Number: 606814960

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Phoenix Diagnostics - 00853366007295 Catalog Number : 16-219

Device Description : Na / Cl Calibrator for Roche / Hitachi Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007301 Catalog Number :

Device Description : Na+ Electrode for Roche / Hitachi Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007318 Catalog Number :

Device Description : K+ Electrode for Roche / Hitachi Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007325 Catalog Number :

Device Description : Cl- Electrode for Roche / Hitachi Chemistry Systems

Device Class : 2

Duns Number: 606814960

Premarket Exempt : No

Product Code : CGZ

Prescription Use : No

Device Count : 1

PHOENIX DIAGNOSTICS, INC. - 00853366007332 Catalog Number :

Device Description : Reference Electrode for Roche / Hitachi Chemistry Systems

Device Class : 1

Duns Number: 606814960

Premarket Exempt : No

Product Code : JJP

Prescription Use : No

Device Count : 1

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