Siemens Healthcare Diagnostics Inc.

Address:430 S Beiger St,Mishawaka,IN,46544,US

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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

CALIBRATOR, SECONDARY (JIT) (2) ALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES (CJO) (1)

Premarket Exempt

No Yes

Clear

Dimension® ALPI CAL - 00842768039027 Catalog Number : DC150

Device Description : Alkaline Phosphatase calibrator, 3x2x1mL

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Dimension Vista® Flex® reagent cartridge ALPI - 00842768039034 Catalog Number : K2115

Device Description : Alkaline Phosphatase Flex® reagent cartridge, 1600 tests

Device Class :

Duns Number: 005088112

Premarket Exempt : No

Product Code : CJO

Prescription Use : No

Device Count : 4

Dimension Vista® ALPI CAL - 00842768039041 Catalog Number : KC331

Device Description : Alkaline Phosphatase Calibrator, 3 x 1mL

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

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