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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3) Calibrator, Multi-Analyte Mixture (JIX) (2) Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (DLI) (1) Differential Rate Kinetic Method, Cpk Or Isoenzymes (JHS) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1) Catalytic Methods, Amylase (JFJ) (1) Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control (LKL) (1)

Premarket Exempt

No Yes

Clear

Clin Chem Control 1 - 08058056680099 Catalog Number : 16150

Device Description : Clin Chem Control 1 is for use in quality control by monitoring accuracy and pre Clin Chem Control 1 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Clin Chem Control 2 - 08058056680105 Catalog Number : 16250

Device Description : Clin Chem Control 2 is for use in quality control by monitoring accuracy and pre Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Clin Chem Cal - 08058056680136 Catalog Number : 16550

Device Description : Clin Chem Cal must be used only for the calibration of clinical chemistry tests. Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

Immuno Control Set - 08058056680204 Catalog Number : 11211A

Device Description : Immuno Control Set is for use in quality control by monitoring accuracy and prec Immuno Control Set is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table.Use the Control Material like the specimens, according to the indicated analytical procedure.For professional use only. For In Vitro diagnostic use.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

CKMB UDR - 08058056680297 Catalog Number : A53720

Device Description : The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitat The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JHS

Prescription Use : Yes

Device Count : 1

Plasmaproteins Cal 3x - 08058056680532 Catalog Number : 11206D

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 with immunoturbidimetric method.Use the Calibrator according to the indicated analytical procedure.For professional use only. For in vitro diagnostics use

Device Class : 2

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : Yes

Device Count : 1

Pancreatic Amylase - 08058056680587 Catalog Number : A53704

Device Description : The Pancreatic Amylase assay is an in vitro diagnostic test used for the determi The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Lipase Color Liquid - 08058056680617 Catalog Number : 17401B

Device Description : The Lipase Color Liquid is an In Vitro Diagnostic test used for the determinatio The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination 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 : No

Product Code : CHI

Prescription Use : Yes

Device Count : 1

alpha 1-Acid Glycoprotein - 08058056680648 Catalog Number : A26838

Device Description : The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprot The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : LKL

Prescription Use : Yes

Device Count : 1

Cholinesterase Liquid - 08058056680709 Catalog Number : 17019H

Device Description : The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determinat The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase 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 : No

Product Code : DLI

Prescription Use : Yes

Device Count : 1

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