KT-031-HEP

Organization name

TAmiRNA GmbH

SRN

AT-MF-000028544

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 2 countries total.

Trade name

not provided

UDI-DI code

D-HEPATOMIRRL

Basic UDI-DI

B-HEPATOMIRRL

Reference / catalog number

KT-031-HEP

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The hepatomiR® kit is a non-automated, quantitative real-time PCR (qRT-PCR) test, including total RNA extraction. The test is intended for the quantitative measurement of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human platelet-poor plasma. The measured ΔCt values are converted into a hepatomiR risk score (0‑1), which is to be used in conjunction with other clinical parameters to support the prognosis of post-hepatectomy liver failure (PHLF) in adult patients being evaluated for liver resection surgery. The test is intended to be used by qualified laboratory professionals trained in qRT‑PCR.

Additional information URL

https://www.tamirna.com/hepatomir-kit-ce-ivd/

Clinical sizes

No clinical sizes registered for this device.

• W01010499MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER

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This device is not currently linked to any other device.