Roche Diagnostics GmbH

Address:NONNENWALD 2,PENZBERG Bavaria,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

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (4) Calibrator, secondary (JIT) (3) COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE (JMM) (1) SYSTEM, TEST, VITAMIN D (MRG) (1) Test, natriuretic peptide (NBC) (1)

Premarket Exempt

No Yes

Clear

cobas pro Transport Belt (2 AU, 2 ISE) - 07613336179536 Catalog Number : 09205713001

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

cobas pro Transport Belt - 07613336179543 Catalog Number : 09205721001

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

cobas pro Transport Belt - 07613336179550 Catalog Number : 09205730001

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

cobas pro SBL e 801 - 07613336179918 Catalog Number : 09211888001

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Elecsys Vitamin D total III - 07613336184615 Catalog Number : 09038078160

Device Description : Vitamin D total G3 Elecsys cobas e 100

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

Elecsys Beta-CrossLaps/serum - 07613336187012 Catalog Number : 09005773160

Device Class : 1

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

Elecsys proBNP II Immunoassay - 07613336191521 Catalog Number : 09315284190

Device Description : proBNP G2 Elecsys E2G 300 V2.1

Device Class : 2

Duns Number: 315028860

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Elecsys proBNP II CalSet - 07613336191538 Catalog Number : 09315292190

Device Description : proBNP G2 CS Elecsys V2.1

Device Class : 2

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Elecsys proBNP II STAT CalSet - 07613336191545 Catalog Number : 09315306190

Device Description : proBNP STAT CS Elecsys V2.1

Device Class : 2

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Elecsys proBNP II CalSet - 07613336191552 Catalog Number : 09315314190

Device Description : proBNP G2 CS Elecsys E2G V2.1

Device Class : 2

Duns Number: 315028860

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

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