Internal Standard Set (IM-A)

Organization name

SHIMADZU CHEMISTRY AND DIAGNOSTICS

SRN

FR-MF-000048960

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 5 countries total.

Trade name

Internal Standard Set (IM-A)

UDI-DI code

03770029302146

Basic UDI-DI

3770029302IMK00TU

Reference / catalog number

227-40175-55

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

DOSIMMUNE is a reagent suite for quantification by LC-MS/MS of the concentration of Cyclosporin A, Everolimus, Sirolimus and Tacrolimus in whole blood specimens from patients undergoing treatment with immunosuppressants. DOSIMMUNE Internal Standard Set (IM-A) is a constitutive component of DOSIMMUNE Reagent suite, used with automated sample preparation, which function is to improve the accuracy and precision of the analytical result by compensating for variations in sample preparation, patient sample composition and signal drift. The set includes a Reconstituton Buffer to dissolve the compounds serving as internal standards.

Additional information URL

https://www.schd-shimadzu.com/

Clinical sizes

No clinical sizes registered for this device.

• W0102080699IMMUNOSUPPRESSANT TDM - OTHER

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• Expiration date
• Manufacturing date
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