DIA-H09

Organization name

BIOZOL Diagnostica Vertrieb GmbH

SRN

DE-MF-000043808

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW045

  - Reagents contain <0.1% sodium azide, which is toxic if ingested and can form explosive metal azides with lead and copper plumbing. Dispose by flushing with large volumes of water.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

DIA-H09

UDI-DI code

04262452791455

Basic UDI-DI

B-04262452791455

Reference / catalog number

DNA-DIA-H09

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

IDH1 R132H (H09) Mouse Monoclonal Antibody is intended for laboratory use in the detection of the IDH1 R132H mutant protein in formalin-fixed, paraffin-embedded human brain tissue stained in qualitative immunohistochemistry on automated IHC instruments or by manual staining protocols. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010113HUMAN ANTI-MOUSE ANTIBODY

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