847-0259200903

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

04262386730032

Basic UDI-DI

426238673025921HY

Reference / catalog number

847-0259200903

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 INSTANT Virus RNA/DNA Kit FX is intended for automated purification of highly pure viral RNA and DNA from cell free human body fluids. 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. With starting volumes of 200, 400 or 800 µl of human plasma and serum, cerebrospinal fluid and swab- and stool-supernatants a throughput of up to 96 samples is possible in parallel. 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