AWARENESS TECHNOLOGY, INCORPORATED

AWARENESS TECHNOLOGY, INCORPORATED

Address:1935 S.W. MARTIN HWY.,PALM CITY,FL,34990,US

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (4) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Coulometric, Chloride (JFS) (1) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Electrode, Ion Specific, Sodium (JGS) (1) Electrode, Ion-Specific, Chloride (CGZ) (1) Electrode, Ion Specific, Potassium (CEM) (1)

Premarket Exempt

No Yes

Clear

Redi-Check Photometer QC - 00850229007119 Catalog Number : E305

Device Description : Photometer Quality Control

Device Class : 2

Duns Number: 071065130

Premarket Exempt : No

Product Code : JFS

Prescription Use : No

Device Count : 1

DriDye 492 - 00850229007164 Catalog Number : E002-492

Device Description : Analyzer Quality Control

Device Class : 1

Duns Number: 071065130

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

DriDye 450 - 00850229007171 Catalog Number : E002-450

Device Description : Analyzer Quality Control

Device Class : 1

Duns Number: 071065130

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

DriDye 405/ 450 - 00850229007188 Catalog Number :

Device Description : Analyzer Quality Control

Device Class : 1

Duns Number: 071065130

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

DriDye 405 - 00850229007195 Catalog Number : E002-405

Device Description : Analyzer Quality Control

Device Class : 1

Duns Number: 071065130

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

ChemWell® FUSION - 00850229007225 Catalog Number : 4800

Device Class : 1

Duns Number: 071065130

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : No

Device Count : 1

SelectaLyte - 00850229007287 Catalog Number :

Device Class : 1

Duns Number: 071065130

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

SelectaLyte (Sodium Electrode) - 00850229007324 Catalog Number :

Device Class : 2

Duns Number: 071065130

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

SelectaLyte (Potassium Electrode) - 00850229007331 Catalog Number :

Device Class : 2

Duns Number: 071065130

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

SelectaLyte (Chloride Electrode) - 00850229007348 Catalog Number :

Device Class : 2

Duns Number: 071065130

Premarket Exempt : No

Product Code : CGZ

Prescription Use : No

Device Count : 1

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