AGAMATRIX, INC.

AGAMATRIX, INC.

Address:7C Raymond Ave,SALEM,NH,03079,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

System, Test, Blood Glucose, Over The Counter (NBW) (9) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No

Clear

AgaMatrix - 00385541000802 Catalog Number :

Device Description : System Kit, Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 00385541001908 Catalog Number :

Device Description : Test Strips, AgaMatrix, Jazz, 10CT

Device Class :

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 10

AgaMatrix - 00385541002103 Catalog Number :

Device Description : Test Strips, AgaMatrix, Jazz, 50CT

Device Class :

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

AgaMatrix - 00385541002509 Catalog Number :

Device Description : Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 00385541002608 Catalog Number :

Device Description : System Kit, Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 00385542649017 Catalog Number :

Device Description : System Kit, Blood Glucose Meter, AgaMatrix, Presto, mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 00385543764023 Catalog Number :

Device Description : Control Solution, AgaMatrix, Combo Normal and High

Device Class : 1

Duns Number: 156756129

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

AgaMatrix - 00385544025017 Catalog Number :

Device Description : System Kit, Blood Glucose Meter, Agamatrix, AMP, mg/dL

Device Class :

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 00385544940013 Catalog Number :

Device Description : System Kit, Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AgaMatrix - 10385541000700 Catalog Number : 8000-10878

Device Description : Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL

Device Class : 2

Duns Number: 156756129

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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