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) (5) Glucose Dehydrogenase, Glucose (LFR) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1)

Premarket Exempt

No Yes

Clear

ACCU-CHEK AVIVA PLUS - 00365702438101 Catalog Number : 06908349001

Device Description : ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702445109 Catalog Number : 06988563001

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

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK PERFORMA - 00365702457102 Catalog Number : 05959551001

Device Description : ACCU-CHEK PERFORMA PROF METER KIT US F2

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK INFORM II - 00365702474109 Catalog Number :

Device Description : ACCU-CHEK LINEARITY KIT U.S.

Device Class : 1

Duns Number: 141608724

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Accu-Chek Fastclix - 00365702481107 Catalog Number : 05864666160

Device Description : Accu-Chek Fastclix MO/RP/AST Kit USA

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRL

Prescription Use : No

Device Count : 1

ACCU-CHEK NANO - 00365702482104 Catalog Number : 06333583001

Device Description : ACCU-CHEK NANO SAMPLE KIT 16/CASE

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK NANO - 00365702483101 Catalog Number : 06333885001

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

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK NANO - 00365702486102 Catalog Number : 06333834001

Device Description : ACCU-CHEK NANO METER ONLY

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK SMART VIEW - 00365702487109 Catalog Number : 06334059001

Device Description : ACCU-CHEK SMART VIEW 10CT STRIP

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK SMART VIEW - 00365702488106 Catalog Number : 06334032001

Device Description : ACCU-CHEK SMART VIEW CONTROL 6/CS

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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