ZUNITY

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW999

  for warnings and precautions see IFU

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095260766

Basic UDI-DI

4049095ZUNITY0000PA

Reference / catalog number

ZUNITY

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

For in vitro diagnostic use. The RIDA®UNITY system is intended for automated nucleic acid purification and PCR analysis of defined human biological samples, in connection with the RIDA®UNITY Extraction Kit, the RIDA®UNITY Internal Control, and the respective RIDA®UNITY PCR assays. The product is intended for professional use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

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