SENTINEL CH. SPA

Address:VIA ROBERT KOCH, 2,MILANO,IT

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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

Indirect Copper Assay, Ceruloplasmin (JFR) (2) Calibrator, Multi-Analyte Mixture (JIX) (2) Kappa, Antigen, Antiserum, Control (DFH) (1) Lambda, Antigen, Antiserum, Control (DEH) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1) Radioassay, Angiotensin Converting Enzyme (KQN) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Calibrator, Secondary (JIT) (1)

Premarket Exempt

No Yes

Clear

Ceruloplasmin - 08058056680730 Catalog Number : 11065N

Device Description : The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric d The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JFR

Prescription Use : Yes

Device Count : 1

Kappa light chains - 08058056681157 Catalog Number : A26845

Device Description : The Kappa light chains assay is an in vitro diagnostic test used for the quantit The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 and Unicel DxC 600 Systems.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : DFH

Prescription Use : Yes

Device Count : 1

Ceruloplasmin - 08058056681232 Catalog Number : A26842

Device Description : The kit is intended for the quantitative determination of ceruloplasmin (CER) in The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JFR

Prescription Use : Yes

Device Count : 1

Lambda light chains - 08058056681263 Catalog Number : A26849

Device Description : The Lambda light chains assay is an in vitro diagnostic test used for the quanti The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : DEH

Prescription Use : Yes

Device Count : 1

Plasmaproteins Cal 3x - 08058056681300 Catalog Number : A26854

Device Description : Plasmaproteins Cal 3x must be used only for the calibration of the plasmaprotein Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

ACE Liquid - 08058056681751 Catalog Number : 1767001

Device Description : ACE Liquid reagent is for use in the determination of Angiotensin converting enz ACE Liquid reagent is for use in the determination of Angiotensin converting enzyme (ACE) activity in human serum or plasma.For In Vitro Diagnostic use.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : KQN

Prescription Use : Yes

Device Count : 1

ACE Calibrator - 08058056681768 Catalog Number : 1665001

Device Description : ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the p ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ACE Control Set - 08058056681775 Catalog Number : 1667001

Device Description : ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monit ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Lipase NG - 08058056681782 Catalog Number : B82715

Device Description : The Lipase NG assay is an in vitro diagnostic test used for the determination on The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : CHI

Prescription Use : Yes

Device Count : 1

Lipase NG Cal - 08058056681799 Catalog Number : B83544

Device Description : Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorim Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric direct determination.For In Vitro Diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

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