MH Guide

Organization name

Molecular Health GmbH

SRN

DE-MF-000012861

Manufacturer status

Active

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• CW010

  The software is to be used neither by untrained personnel nor by patients. The prefilled report is not intended to be shared directly with a physician not trained to use the application. Copy NumberAlteration(CNA) identification from capture-based approaches still has technical limitations. Therefore, CNA variants shall be orthogonally validated prior to basing a treatment recommendation on such variants. Microsatellite Instability (MSI)identification was validated with a limited number of samples that indicate 60% - 100% precision and sensitivity between 75%and 100%. As the determinants for the difference in performance are unknown, it is strongly recommended to assess the MSI status of unclassified cases or MSS cases with orthogonal methods prior to basing a treatment decision on the MSI status. MH Guide is neither for germline predisposition analyses nor to be used as companion diagnostics. MH Guide/BRCA andMHGuide/Mendel are intended neither for tumor analyses nor prenatal testing.

Primary placement in Germany; available across 8 countries total.

Trade name

MH Guide

UDI-DI code

04260563550350

Basic UDI-DI

4260563550237VS

Reference / catalog number

1000000141

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

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• Expiration date
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