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

Hemoglobin A1c test system (PDJ) (2) IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (2) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES (CGS) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) Nadh oxidation/nad reduction, ast/sgot (CIT) (1) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1) Assay, porphyrin, spectrophotometry, lithium (NDW) (1)

Premarket Exempt

No Yes

Clear

Dimension Clinical Chemistry System A1C Kit - 00630414006659 Catalog Number : DF105B

Device Description : A1C Reagent Kit

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : PDJ

Prescription Use : Yes

Device Count : 1

Dimension Vista System Flex reagent cartridge A1C KIT - 00630414006666 Catalog Number : K3105B

Device Description : A1C Reagent Kit

Device Class : 2

Duns Number: 005088112

Premarket Exempt : No

Product Code : PDJ

Prescription Use : No

Device Count : 1

Atellica IM TNIH - 00630414006703 Catalog Number : 10997840

Device Description : High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 100T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 1

Atellica IM TNIH - 00630414006758 Catalog Number : 10997841

Device Description : High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 500T

Device Class :

Duns Number: 064608573

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 5

Atellica IM TNIH MCM - 00630414006772 Catalog Number : 10997842

Device Description : High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Atellica CH Li - 00630414006789 Catalog Number : 11097535

Device Description : Lithium (Lith) Atellica CH - RGT 400T

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : NDW

Prescription Use : No

Device Count : 1

Atellica IM 1300 Analyzer - 00630414007960 Catalog Number : 11066001

Device Description : Atellica IM 1300 Analyzer

Device Class : 1

Duns Number: 064608573

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

ADVIA Chemistry Creatine Kinase - 00630414008943 Catalog Number : 10729780

Device Description : 4 wedges per reagent , 2 reagent, 1100 test per carton

Device Class : 2

Duns Number: 064608573

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

ADVIA Chemistry P5PL_c Reagent - 00630414008950 Catalog Number : 10729782

Device Description : ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc

Device Class : 1

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : CIT, CKA

Prescription Use : Yes

Device Count : 6

ADVIA® Chemistry Enzyme 1 Calibrator - 00630414008967 Catalog Number : 10916057

Device Description : Enzyme 1 Calibrator - ADVIA Chemistry (ENZ 1 CAL)

Device Class : 2

Duns Number: 064608573

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

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