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) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (3) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (2) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (2) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (2) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (2) TEST, TIME, PROTHROMBIN (GJS) (1) Enzyme immunoassay, opiates (DJG) (1) RADIOASSAY, VITAMIN B12 (CDD) (1) Calibrators, drug specific (DLJ) (1)

Premarket Exempt

No Yes

Clear

Emit II Plus Oxycodone Negative Control 300 - 00630414027982 Catalog Number : 9T709UL

Device Description : Emit II Plus Oxycodone Negative Control 300

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Emit II Plus Oxycodone Positive Control 100 - 00630414027999 Catalog Number : 9T619UL

Device Description : Emit II Plus Oxycodone Positive Control 100

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Emit II Plus Oxycodone Negative Control 100 - 00630414028002 Catalog Number : 9T609UL

Device Description : Emit II Plus Oxycodone Negative Control 100

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Emit II Plus Oxycodone Assay 30 mL Kit - 00630414028019 Catalog Number : 9T039UL

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 1 - 00630414028026 Catalog Number : 9T529UL

Device Description : Emit II Plus Specialty Multi Drug Calibrator/Control Level 1

Device Class : 1

Duns Number: 005088112

Premarket Exempt : Yes

Product Code : LAS, DLJ

Prescription Use : No

Device Count : 1

Xprecia™ System PT/INR Strips - 00630414034348 Catalog Number : 11065645

Device Description : Xprecia™ System PT/INR Strips, is intended for use by professional healthcare pr Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International NormalizedRatio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 100

Ready Sensor™ Lactate Biosensor - 00630414051499 Catalog Number : 102455

Device Description : Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the m Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Lactate Warranty Replacement

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : CHL

Prescription Use : No

Device Count : 1

RAPIDLab® 348 Wash - 00630414053448 Catalog Number : 104226

Device Description : RAPIDLab® 348/348EX Wash Reagent for in vitro diagnostics use with the RAPIDLab® RAPIDLab® 348/348EX Wash Reagent for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : JGS, CHL, CEM, JFP, CGZ

Prescription Use : No

Device Count : 4

RAPIDLab® 348 6.8/7.3 Buffer Pack - 00630414053455 Catalog Number : 104227

Device Description : RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : JFP, CGZ, CEM, CHL, JGS

Prescription Use : No

Device Count : 1

ADVIA Centaur® VB12 MCM - 00630414054124 Catalog Number : 104523

Device Description : Vitamin B12 - Master Curve Material Set - CENTAUR - CONS

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : CDD

Prescription Use : No

Device Count : 1

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