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

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (4) ASSAY, GLYCOSYLATED HEMOGLOBIN (LCP) (3) Hemoglobin A1c test system (PDJ) (3) Calibrator, secondary (JIT) (1) Drug mixture control materials (DIF) (1) NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES (CGS) (1)

Premarket Exempt

No Yes

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Atellica Direct Load - 00630414002347 Catalog Number : 11068008

Device Description : Atellica DL MODULE

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica Direct Load Kit - 00630414002354 Catalog Number : 11068009

Device Description : Atellica DL PRIMARY KIT

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica Sample Handler Prime - 00630414002439 Catalog Number : 11069001

Device Description : Atellica SAMPLE HANDLER PRIMARY MODULE

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica Sample Handler Additional - 00630414002460 Catalog Number : 11069004

Device Description : Atellica SAMPLE HANDLER ADDITIONAL MODULE

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Atellica CH MULTIDRUG QC - 00630414002699 Catalog Number : 11099406

Device Description : Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 3

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002859 Catalog Number : 10720857

Device Description : ADVIA A1c_E Reagent (Small Kit), 300 tests

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : LCP, PDJ

Prescription Use : No

Device Count : 1

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002866 Catalog Number : 10720858

Device Description : ADVIA A1c_E Reagent (Large Kit), 1200 tests

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : LCP, PDJ

Prescription Use : No

Device Count : 1

ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator - 00630414002873 Catalog Number : 10720859

Device Description : ADVIA A1c_E Calibrator, 1x 3mL

Device Class : 2

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment - 00630414002880 Catalog Number : 10721048

Device Description : ADVIA A1c_E Pretreatment Solution, 1L

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : LCP, PDJ

Prescription Use : No

Device Count : 1

Atellica CH CK_L - 00630414006642 Catalog Number : 11097640

Device Description : Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 1

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