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

Single (specified) analyte controls (assayed and unassayed) (JJX) (3) Counter, differential cell (GKZ) (2) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (1) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (1) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (1) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (1) Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific (LGC) (1) Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 (MXJ) (1) Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 (MYF) (1) GLUCOSE OXIDASE, GLUCOSE (CGA) (1) INSTRUMENT, HEMATOCRIT, AUTOMATED (GKF) (1) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (1)

Premarket Exempt

No Yes

Clear

Dimension® EXL™ with LM Integrated Chemistry System - 00630414014128 Catalog Number : 778020.911

Device Description : Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)

Device Class : 1

Duns Number: 005088112

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Dimension® EXL™ with LM Integrated Chemistry System - 00630414014135 Catalog Number : 759020.911

Device Description : Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management Sys Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management System (RMS) and Sample Transfer Module (STM)

Device Class : 1

Duns Number: 005088112

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica IM PCT MCM - 00630414014197 Catalog Number : 10998265

Device Description : Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

RAPIDSystems™ AutomaticQC Cartridge - 00630414016627 Catalog Number : 11046781

Device Description : for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 s for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

ADVIA Centaur Herpes-2 IgG - 00630414016726 Catalog Number : 10720849

Device Description : Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : LGC, MYF

Prescription Use : No

Device Count : 1

ADVIA Centaur Herpes-2 IgG Quality Control - 00630414016733 Catalog Number : 10720850

Device Description : Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ADVIA Centaur Herpes-1 IgG - 00630414016740 Catalog Number : 10720846

Device Description : Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : MXJ

Prescription Use : No

Device Count : 1

ADVIA Centaur Herpes-1 IgG Quality Control - 00630414016757 Catalog Number : 10720847

Device Description : Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ADVIA 2120i with DAA Autosampler - 00630414019772 Catalog Number : 11219529

Device Description : ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : GKZ

Prescription Use : No

Device Count : 1

ADVIA 2120i with SAA Autosampler - 00630414019789 Catalog Number : 11219530

Device Description : ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : GKZ

Prescription Use : No

Device Count : 1

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