Matrix Standard BT5 multi

Organization name

BIOTYPE GmbH

SRN

DE-MF-000025906

Manufacturer status

Active

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• CW010

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• CW032

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• CW132

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Primary placement in Germany; available across 12 countries total.

Trade name

Matrix Standard BT5 multi

UDI-DI code

04251935200751

Basic UDI-DI

42519352MATRIXSTANDBT5M8U

Reference / catalog number

45-15100-0025

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Matrix Standard BT5 multi is a reagent used to manually generate a matrix for the spectral alignment of the Applied Biosystems® 3500 and SeqStudioTM Genetic Analyzer (Thermo Fisher Scientific). It is required to analyze PCR products of the IVD products Mentype® AMLplexQS PCR Amplification Kit, Mentype® Chimera® PCR Amplification Kit and Mentype® DIPscreen PCR Amplification Kit. The matrix is used by the device software to automatically analyze the five different fluorescent signals of the PCR products in one capillary. The Matrix Standard BT5 multi is a mixture of five PCR amplicons, each labeled with one of the five fluorophores 6-FAMTM, BTG, BTY, BTO, BTR. By analyzing these oligonucleotides, the spectral overlap between the emission spectra of the dyes is calculated and corrected, enabling the simultaneous analysis of all five dyes in one capillary.

Additional information URL

https://www.biotype.de/en/ifus

Clinical sizes

No clinical sizes registered for this device.

• W0580IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES

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