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

Glucose Dehydrogenase, Glucose (LFR) (6) System, Test, Blood Glucose, Over The Counter (NBW) (2) Accessories, Pump, Infusion (MRZ) (1) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1)

Premarket Exempt

No Yes

Clear

ACCU-CHEK SMART VIEW - 00365702492103 Catalog Number : 06337538001

Device Description : ACCU-CHEK SMART VIEW 50CT STRIP 36/CS

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK SMART VIEW - 00365702493100 Catalog Number : 06337546001

Device Description : ACCU-CHEK SMART VIEW 100CT STRIP 24/CS

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 2

ACCU-CHEK SMART VIEW - 00365702494107 Catalog Number : 06337554001

Device Description : ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK SMART VIEW - 00365702495104 Catalog Number :

Device Description : ACCU-CHEK SMART VIEW MAIL ORDER STRIP 36

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK 360 - 00365702508101 Catalog Number : 06604765001

Device Description : ACCU-CHEK 360 INSULIN PUMP CONFIG SW US

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : MRZ

Prescription Use : No

Device Count : 1

ACCU-CHEK SMART VIEW - 00365702514102 Catalog Number : 06648266001

Device Description : ACCU-CHEK SMART VIEW CONTROL 2

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA - 00365702544109 Catalog Number :

Device Description : ACCU-CHEK AVIVA MG/DL 455 US

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Accu-Chek Coaguchek Softclix - 00365702562103 Catalog Number : 06979009001

Device Description : CoaguChek Softclix Lancets 25ct 100/cs

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRL

Prescription Use : No

Device Count : 1

ACCU-CHEK NANO - 00365702567108 Catalog Number : 07008325001

Device Description : ACCU-CHEK NANO RETAIL KIT DSGNR 8/CASE

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA EXPERT - 00365702575103 Catalog Number : 06699430001

Device Description : ACCU-CHEK AVIVA EXPERT KIT US

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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