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

Multi-analyte controls, all kinds (assayed) (JJY) (3) Calibrator, multi-analyte mixture (JIX) (2) KAPPA, ANTIGEN, ANTISERUM, CONTROL (DFH) (2) LAMBDA, ANTIGEN, ANTISERUM, CONTROL (DEH) (2) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) TEST, CYSTATIN C (NDY) (1)

Premarket Exempt

No Yes

Clear

N LATEX FLC KAPPA - 00630414167657 Catalog Number : OPJA075

Device Description : Quantitative determination of free light chains (FLC) type kappa in human serum Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : DFH

Prescription Use : No

Device Count : 3

N LATEX FLC lambda - 00630414167664 Catalog Number : OPJB07

Device Description : Quantitative determination of free light chains (FLC) type lambda in human serum Quantitative determination of free light chains (FLC) type lambda in human serum and EDTA-plasma on Siemens analyzers

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : DEH

Prescription Use : No

Device Count : 3

N Latex Cystatin C - 00630414167824 Catalog Number : OQNM19

Device Description : Quantitative determination of cystatin C in human serum and lithium-heparinized Quantitative determination of cystatin C in human serum and lithium-heparinized plasma on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : NDY

Prescription Use : No

Device Count : 1

N Protein Standard UY - 00630414167848 Catalog Number : 10873632

Device Description : Calibration of Human a1-microglobulin and cystatin C assays on BN Systems

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 3

N FLC SUPPLEMENTARY REAGENT - 00630414237473 Catalog Number : OPJC05

Device Description : Immunonephelometric determination of free light chains (FLC) type kappa and type Immunonephelometric determination of free light chains (FLC) type kappa and type lambda on BN Systems.

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : DFH, DEH

Prescription Use : No

Device Count : 1

N FLC CONTROL SL1 - 00630414237480 Catalog Number : OPJE05

Device Description : Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems.

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 3

N FLC STANDARD SL - 00630414237497 Catalog Number : OPJD05

Device Description : Establishment of reference curves for the determination of free light chains (FL Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on BN Systems.

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 3

N FLC CONTROL SL2 - 00630414237503 Catalog Number : OPJF05

Device Class :

Duns Number: 388240673

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 3

N Rheumatology Standard SL - 00630414284972 Catalog Number : OQKZ15

Device Description : Calibration of RF, ASL and CRP assays on BN Systems

Device Class : 2

Duns Number: 388240673

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 3

N/T Rheumatology Control SL/1 - 00630414284989 Catalog Number : OQDB17

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

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