FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

Organization name

Genekam Biotechnology AG

SRN

DE-MF-000035227

Manufacturer status

Active

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

• CW007

  If the packing box and the tubes are damaged, don´t use the kit.
• CW010

  User must read the manual before the use of the kit.

Primary placement in Germany; available across 32 countries total.

Trade name

FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

UDI-DI code

04262420430225

Basic UDI-DI

426242043GEN111SF

Reference / catalog number

FR118

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

FR118-Human specific DNA-Internal Control (Realtime PCR-Kit) is intented to be used as internal control for in vitro diagnostic procedures in connection with specific investigations like pathogen specific real time PCR assay, but also non pathogen specific real time PCR assay. It shows the results in form of Ct values, which can be compared between the samples.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105080908STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT

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