847-0259200906

Organization name

Roboscreen GmbH

SRN

DE-MF-000024661

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW265

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04262386730056

Basic UDI-DI

426238673025922J2

Reference / catalog number

847-0259200906

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

Rapid INSTANT Virus RNA/DNA Kit FX is intended for automated isolation of viral RNA and DNA from 400 µl of cell-free human body fluids and is optimized for a minimal processing time. The extraction procedure is based on the magnetic particle binding technology and is optimized for rapid preparation of highly pure viral RNA and DNA from human plasma and serum, cerebrospinal fluid and swab- and stool-supernatants. Rapid INSTANT Virus RNA/DNA Kit – FX is configured for exclusive use in combination with the CyBio FeliX Basic Unit equipped with the CyBio FeliX Extraction Set, thereby allowing simultaneous processing of up to 96 samples. The kit is intended to be applied by professional users in a laboratory environment.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS