Roche Diagnostics Operations, Inc.

Address:9115 Hague Rd,Indianapolis,IN,46250,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) (6) Glucose Dehydrogenase, Glucose (LFR) (4)

Premarket Exempt

No Yes

Clear

ACCU-CHEK AVIVA CONNECT - 00365702576100 Catalog Number : 07049692001

Device Description : ACCU-CHEK AVIVA CONNECT SAMPLE KIT 16/CASE

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA CONNECT - 00365702577107 Catalog Number : 07049706001

Device Description : ACCU-CHEK AVIVA CONNECT RETAIL KIT 8/CASE

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA CONNECT - 00365702578104 Catalog Number : 07049811001

Device Description : ACCU-CHEK AVIVA CONNECT MG/DL M-O

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA EXPERT - 00365702580107 Catalog Number : 07162758001

Device Description : ACCU-CHEK AVIVA EXPERT CUSTOMER PACK

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA CONNECT - 00365702593107 Catalog Number : 06979505001

Device Description : ACCU-CHEK AVIVA CONNECT MG/DL (502)

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA EXPERT - 00365702594104 Catalog Number : 07189486001

Device Description : ACCU-CHEK AVIVA EXPERT DEMO CUSTOMER PK

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA EXPERT - 00365702595101 Catalog Number : 07189494001

Device Description : ACCU-CHEK AVIVA EXPERT DEMO KIT

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK PERFORMA - 00365702602106 Catalog Number : 07299702001

Device Description : ACCU-CHEK PERFORMA US 50 CT 36/CS F2

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Accu-Chek Guide - 00365702609105 Catalog Number :

Device Description : ACCU-CHEK GUIDE MG/DL METER 923 (US)

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK NANO - 00365702637108 Catalog Number :

Device Description : ACCU-CHEK NANO MTR MG/DL (596)

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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