Siemens Healthcare Diagnostics Products GmbH

Address:76 EMIL-VON-BEHRING STRASSE,MARBURG Hesse,DE

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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

ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP. (GTR) (1) Calibrator, multi-analyte mixture (JIX) (1) Calibrator, primary (JIS) (1) IGA, ANTIGEN, ANTISERUM, CONTROL (CZP) (1) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) (CFN) (1) MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL (DDR) (1) Multi-analyte controls, all kinds (assayed) (JJY) (1) SLIDE STAINER, AUTOMATED (KPA) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

N/T Rheumatology Control SL/2 - 00630414284996 Catalog Number : OQDC17

Device Description : Assayed control for RF, ASL and CRP assays on BN Systems

Device Class : 1

Duns Number: 388240673

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 3

N LP(a) Standard SY - 00630414285009 Catalog Number : OQCV07

Device Description : Calibration of Lp(a) assay on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 3

N Lp(a) Control SY - 00630414285016 Catalog Number : OQCW07

Device Description : Assayed control for Lp(a) assay on BN Systems

Device Class : 1

Duns Number: 388240673

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 3

N Latex IgM - 00630414285023 Catalog Number : OQAC15

Device Description : Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : CFN

Prescription Use : No

Device Count : 1

N Latex IgA - 00630414285030 Catalog Number : OQAI15

Device Description : Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : CZP

Prescription Use : No

Device Count : 1

N Latex Myoglobin - 00630414285047 Catalog Number : OWIA17

Device Description : Quantitative determination of myoglobin in human serum and plasma on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : DDR

Prescription Use : No

Device Count : 1

N Latex ADNase B (USA) - 00630414285054 Catalog Number : OWTI15

Device Description : Quantitative determination of ADNase B in human serum on BN Systems

Device Class : 1

Duns Number: 388240673

Premarket Exempt : Yes

Product Code : GTR

Prescription Use : No

Device Count : 1

N Protein Standard SL - 00630414285061 Catalog Number : OQIM19

Device Description : N Protein Standard SL is a multi-analyte calibrator for the establishment of ref N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the BN Systems

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 3

Hematek® 3000 System - 00630414596563 Catalog Number : 10805311

Device Description : The Hematek slide stainer is a fully automated, bench-top hematology system for The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy

Device Class : 1

Duns Number: 388240673

Premarket Exempt : No

Product Code : KPA

Prescription Use : No

Device Count : 1

BCS® XP System - 00630414945514 Catalog Number : OVOB03

Device Description : The Behring Coagulation System (BCS XP System) performs quantitative assays of s The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : GKP

Prescription Use : No

Device Count : 1

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