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) Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (FMK) (1)

Premarket Exempt

No Yes

Clear

Accu-Chek Softclix - 00075537009710 Catalog Number : 11893238160

Device Description : Accu-Chek Softclix Lancets 100ct 12/cs

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 1

Accu-Chek Safe-T-Pro - 00075537257890 Catalog Number : 03448622001

Device Description : Accu-Chek Safe-T-Pro Plus 200ct

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

ACCU-CHEK COMPACT PLUS - 00075537490709 Catalog Number :

Device Description : ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702101104 Catalog Number : 06988580001

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

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702102101 Catalog Number : 06988601001

Device Description : ACCU-CHEK AVIVA PLUS METER-ONLY

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK Aviva - 00365702107106 Catalog Number :

Device Description : ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702134102 Catalog Number : 07021941001

Device Description : ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Accu-Chek Softclix - 00365702156104 Catalog Number : 04980263001

Device Description : Accu-Chek Softclix HN Lancets 100ct 12cs

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 1

ACCU-CHEK COMPACT PLUS - 00365702192102 Catalog Number : 05907675001

Device Description : ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ACCU-CHEK COMPACT PLUS - 00365702220102 Catalog Number :

Device Description : ACCU-CHEK COMPACT PLUS DME KIT

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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