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

Drug specific control materials (LAS) (4) Calibrators, drug specific (DLJ) (3) Enzyme immunoassay, opiates (DJG) (2) KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS (LOK) (1) PLASMA, COAGULATION CONTROL (GGN) (1) TEST, TIME, PROTHROMBIN (GJS) (1) Counter, differential cell (GKZ) (1) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (1)

Premarket Exempt

No Yes

Clear

ADVIA 2120i wthout Autosampler - 00630414019796 Catalog Number : 11219531

Device Description : ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : GKZ

Prescription Use : No

Device Count : 1

ADVIA Centaur® AFP - 00630414022963 Catalog Number : 10998577

Device Description : Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T

Device Class : 3

Duns Number: 064608573

Premarket Exempt : No

Product Code : LOK

Prescription Use : No

Device Count : 1

Xprecia Stride™ Coagulation Analyzer - 00630414025148 Catalog Number : 11065584

Device Description : The Xprecia Stride™ Coagulation System is intended for use by professional healt The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : GGN, GJS

Prescription Use : Yes

Device Count : 1

DCA® Systems Microalbumin/Creatinine Capillary holders and plungers - 00630414027364 Catalog Number : 10888739

Device Description : A urine collection tube holder and plunger; to be used with DCA® Systems Microal A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : JIR

Prescription Use : No

Device Count : 10

Emit II Plus Oxycodone Assay 1 L Kit - 00630414027920 Catalog Number : 9T129UL

Device Description : Emit II Plus Oxycodone Assay

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

Emit II Plus Oxycodone Assay 115 mL Kit - 00630414027937 Catalog Number : 9T029UL

Device Description : Emit II Plus Oxycodone Assay

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 - 00630414027944 Catalog Number : 9T589UL

Device Description : Emit II Plus Specialty Multi Drug Calibrator/Control Level 4

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS, DLJ

Prescription Use : No

Device Count : 1

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 - 00630414027951 Catalog Number : 9T569UL

Device Description : Emit II Plus Specialty Multi Drug Calibrator/Control Level 3

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS, DLJ

Prescription Use : No

Device Count : 1

Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 - 00630414027968 Catalog Number : 9T549UL

Device Description : Emit II Plus Specialty Multi Drug Calibrator/Control Level 2

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS, DLJ

Prescription Use : No

Device Count : 1

Emit II Plus Oxycodone Positive Control 300 - 00630414027975 Catalog Number : 9T719UL

Device Description : Emit II Plus Oxycodone Positive Control 300

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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