RNAscope™ ISH Probe dapB (Negative Control)

Organization name

Advanced Cell Diagnostics

SRN

US-MF-000047789

Manufacturer status

Active

D-200470LS

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

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

• Avoid direct contact with the probe. Use appropriate personal protective equipment (PPE) to prevent exposure to eyes, skin, and mucous membranes. If exposure occurs, wash liberally with water.

  OTHER

• GHS08 - Danger or Warning - Systemic health hazards

  Formamide (≤ 50%)

• H351 – Suspected of causing cancer.
• H360 – May damage fertility or the unborn child.
• H373 – May cause damage to organs through prolonged or repeated exposure.
• P201 – Obtain special instructions before use.
• P202 – Do not handle until all safety precautions have been read and understood.
• P281 – Use personal protective equipment as required.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P308 – IF exposed or concerned: P314 – Get medical advice/attention if you feel unwell.
• P405 Store locked up.

  OTHER

• P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

  OTHER

• Probe contains material of animal origin. Consider all materials of human or animal origin as a risk for transmitting infection. Take adequate precautions for handling and ensuring proper disposal.

  OTHER

• Microbial contamination can lead to inaccurate results.

  OTHER

• Refer to the Safety Data Sheet for additional safety information available at www.bio-techne.com.

  OTHER

• Consult relevant local authorities and regulations for proper disposal of the probe.

  OTHER

Primary placement in France; available across 9 countries total.

Trade name

RNAscope™ ISH Probe dapB (Negative Control)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-200470LS

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-200470LS

Reference / catalog number

200470

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

RNAscope ISH Probe dapB (Negative Control) is intended for use as a negative control in a RNAscope in situ hybridization (ISH) assay in formalin-fixed paraffin-embedded (FFPE) tissue specimens. The probe targets mRNA transcripts of the dihydrodipicolinate reductase gene of Bacillus subtilis. The probe is for use in clinical laboratories with BOND RNAscope Brown Detection on the automated Leica Biosystems BOND-III stainer. The clinical interpretation of any hybridization signal or its absence should be performed by a qualified pathologist with proper controls, complemented by histological examination and relevant clinical information.

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.

• W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

• IVDD — General medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.