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

Bromcresol Purple Dye-Binding, Albumin (CJW) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Calibrator, Secondary (JIT) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1)

Premarket Exempt

No Yes

Clear

CRP Ultra (MP) - 08058056681911 Catalog Number : 115646

Device Description : Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentr Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System. The assay is intended for professional use only. For In Vitro diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

Albumin BCP (6x20 mL) - 08058056681973 Catalog Number : C22855

Device Description : The Albumin BCP (6x20 mL) assay is an in vitro diagnostic test used for the dete The Albumin BCP (6x20 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : CJW

Prescription Use : Yes

Device Count : 1

Albumin BCP (6x50 mL) - 08058056681980 Catalog Number : C22856

Device Description : The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the dete The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : No

Product Code : CJW

Prescription Use : Yes

Device Count : 1

Lipase NG OC Cal - 08058056682291 Catalog Number : 04Y85-01

Device Description : Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitr Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.

Device Class : 2

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Lipase NG OC CTRL 1 - 08058056682307 Catalog Number : 04Y85-10

Device Description : Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Lipase NG OC CTRL 2 - 08058056682314 Catalog Number : 04Y85-11

Device Description : Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Lipase NG OC Reagent Kit - 08058056682321 Catalog Number : 04Y85-20

Device Description : The Lipase NG OC assay is an in vitro diagnostic test used for the determination The Lipase NG OC assay 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. For In Vitro Diagnostic use.

Device Class : 1

Duns Number: 429572365

Premarket Exempt : Yes

Product Code : CHI

Prescription Use : Yes

Device Count : 1

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