SB0001-Genekam Universal DNA-Isolation Kit (INT)

Organization name

Genekam Biotechnology AG

SRN

DE-MF-000035227

Manufacturer status

Active

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

• CW007

  If the packing box and the bottles are damaged, don´t use the kit.
• CW041

  EUDAMED did not publish a description for this code.
• CW043

  EUDAMED did not publish a description for this code.
• CW076

  Immediately seek medical advice.
• CW081

  Remove contaminated clothing. Wash the affected skin or mucous membrane thoroughly under running water. (If possible) use soap. Immediately seek medical advice.
• CW084

  After contact with the eyes wash thoroughly under running water with the eyelid wide open with eye washing bottle, eye douche or running water (protect intact eye). Immediately seek medical advice.
• CW416

  Immediately seek medical advice.
• CW167

  EUDAMED did not publish a description for this code.
• CW430

  Immediately seek medical advice.
• CW010

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

Primary placement in Germany; available across 32 countries total.

Trade name

SB0001-Genekam Universal DNA-Isolation Kit (INT)

UDI-DI code

04262420430706

Basic UDI-DI

426242043DNAISO23

Reference / catalog number

SB0001

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 kit serves as a basis for molecular biology, for the isolation and purification of genomic DNA from human samples to conduct in vitro diagnostic procedures in connection with specific investigations, such as conventional PCR, real-time PCR assays and genesequencing and hybridization methods.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER

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