VERTEX DIAGNOSTICS LLC

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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) (4) Glucose Oxidase, Glucose (CGA) (2) Glucose Dehydrogenase, Glucose (LFR) (1)

Premarket Exempt

Clear

UltraTRAK TM Complete Blood Glucose Monitoring System - 00385930000000 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

UltraTRAK Complete 50 Test Strips - 00385930000017 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

UltraTRAK TM 50 Test Strips - 00385930011013 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

Ultra TRAK PRO Blood Glucose Monitoring System - 00385930011020 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

UltraTRAK PRO Blood Glucose Monitoring System - 00385930011082 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

UltraTrak TM ULTIMATE Blood Glucose Monitoring System - 00385930011099 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips) - 00385930011112 Catalog Number :

Device Class : 2

Duns Number: 808107788

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

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