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

CALIBRATORS, DRUG MIXTURE (DKB) (3) DRUG MIXTURE CONTROL MATERIALS (DIF) (3) ENZYME IMMUNOASSAY, OPIATES (DJG) (2) ENZYME IMMUNOASSAY, DIGITOXIN (LFM) (1) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) RADIOASSAY, VITAMIN B12 (CDD) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) CALIBRATOR, SECONDARY (JIT) (1)

Premarket Exempt

No Yes

Clear

Dimension® Flex® reagent cartridge CHK - 00842768033124 Catalog Number : DF179

Device Description : CHK Flex® reagent cartridge, 8 Flex® reagent cartridges

Device Class :

Duns Number: 005088112

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 8

Dimension Vista® Flex® reagent cartridge DGTX - 00842768033315 Catalog Number : K4036A

Device Description : Digitoxin Flex® reagent cartridge, 40 tests

Device Class :

Duns Number: 005088112

Premarket Exempt : No

Product Code : LFM

Prescription Use : No

Device Count : 2

Dimension Vista® DGTX CAL - 00842768033322 Catalog Number : KC470

Device Description : DGTX Calibrator, 2x5x5.0mL

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Dimension Vista® Flex® reagent cartridge VB12 - 00842768033810 Catalog Number : K6442A

Device Description : LOCI Vitamin B12 Flex® reagent cartridge, 120 tests

Device Class :

Duns Number: 005088112

Premarket Exempt : No

Product Code : CDD

Prescription Use : No

Device Count : 4

Dimension Vista® LOCI 4 CAL - 00842768033827 Catalog Number : KC640A

Device Description : LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL; 2C x 2.0 mL;2D x 2.0 mL; 2E x 2.0 mL)

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

Syva® Emit® II Plus 6-Acetylmorphine Assay - 00842768034114 Catalog Number : 9R039UL

Device Description : Syva® Emit® II Plus 6-Acetylmorphine Assay - 28 mL Kit

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

Syva® Emit® II Plus 6-Acetylmorphine Assay - 00842768034121 Catalog Number : 9R129UL

Device Description : Syva® Emit® II Plus 6-Acetylmorphine Assay - 1 L kit

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 - 00842768034138 Catalog Number : 9R529UL

Device Description : Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1

Device Class : 1

Duns Number: 005088112

Premarket Exempt : No

Product Code : DKB, DIF

Prescription Use : No

Device Count : 1

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 - 00842768034145 Catalog Number : 9R549UL

Device Description : Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2

Device Class : 1

Duns Number: 005088112

Premarket Exempt : No

Product Code : DKB, DIF

Prescription Use : No

Device Count : 1

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 - 00842768034152 Catalog Number : 9R569UL

Device Description : Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3

Device Class : 1

Duns Number: 005088112

Premarket Exempt : No

Product Code : DIF, DKB

Prescription Use : No

Device Count : 1

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