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

Premarket Exempt

No Yes

Clear

ACCU-CHEK Inform II - 00365702237100 Catalog Number :

Device Description : Accu-Chek Inform II controls US 10/CS

Device Class : 1

Duns Number: 141608724

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Accu-Chek Fastclix - 00365702288102 Catalog Number : 05360145001

Device Description : Accu-Chek Fastclix 102 Lancets Rtl 12/cs

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRL

Prescription Use : No

Device Count : 1

Accu-Chek Fastclix - 00365702291102 Catalog Number : 05360188001

Device Description : Accu-Chek Fastclix 102 Lancets DME 12/cs

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRL

Prescription Use : No

Device Count : 1

Accu-Chek Softclix - 00365702400108 Catalog Number : 05509661001

Device Description : Accu-Chek Softclix (black) USA 12/case

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702405103 Catalog Number : 06908152001

Device Description : ACCU-CHEK AVIVA PLUS 10CT STRIP BRK

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702407107 Catalog Number : 06908217001

Device Description : ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702408104 Catalog Number : 06908268001

Device Description : ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 2

ACCU-CHEK INFORM II - 00365702428102 Catalog Number : 05942861001

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

Device Class : 2

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

ACCU-CHEK AVIVA PLUS - 00365702436107 Catalog Number :

Device Description : ACCU-CHEK AVIVA PLUS 50 MLRDR 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 - 00365702437104 Catalog Number : 06908314001

Device Description : ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C

Device Class :

Duns Number: 141608724

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

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