Roche Diagnostics GmbH

Address:SANDHOFER STRASSE 116,MANNHEIM Baden-Wurttemberg,DE

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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

TEST, TIME, PROTHROMBIN (GJS) (5) Single (specified) analyte controls (assayed and unassayed) (JJX) (2) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) PLASMA, COAGULATION CONTROL (GGN) (1)

Premarket Exempt

No Yes

Clear

Chemstrip 7 Test Strips - 00075537671603 Catalog Number : 11008552160

Device Class : 1

Duns Number: 315028860

Premarket Exempt : No

Product Code : CDM

Prescription Use : Yes

Device Count : 1

CoaguChek XS Patient Self Testing Care Kit - 00365702125100 Catalog Number : 4837738001

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

CoaguChek XS Professional Use Care Kit - 00365702126107 Catalog Number : 4837975001

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

COAGUCHEK XS PT TEST 6 STRIP - 00365702127104 Catalog Number : 4625374160

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

CoaguChek XS PT strips - 00365702128101 Catalog Number : 4625315160

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

CoaguChek XS Pro PT controls - 00365702129108 Catalog Number : 4625382160

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 1

CoaguChek XS Plus Professional Care Kit - 00365702164109 Catalog Number : 5021537001

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Accutrend Cholesterol Controls - 00365702250109 Catalog Number : 5219957001

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Accutrend Glucose Controls - 00365702275102 Catalog Number : 5213231160

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Accutrend Plus Cholesterol strips - 00365702276109 Catalog Number : 05213312160

Device Class : 1

Duns Number: 315028860

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

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