ED7043

Organization name

EXBIO Praha, a.s.

SRN

CZ-MF-000033468

Manufacturer status

Active

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

• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P233 – Keep container tightly closed.
• Consult instructions for use
• Contains biological material of human origin

  Albumin from human serum

• Contains human blood or plasma derivatives
• Do not use past indicated date
• EUH 071 – Corrosive to the respiratory tract.
• H315 – Causes skin irritation.
• H317 – May cause an allergic skin reaction.
• H319 – Causes serious eye irritation.
• H331 – Toxic if inhaled.
• H335 – May cause respiratory irritation.
• H341 – Suspected of causing genetic defects.
• H350 – May cause cancer.
• P201 – Obtain special instructions before use.
• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.

Primary placement in Czechia; available across 15 countries total.

Trade name

not provided

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.

08594208060130

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.

859420806ED704364

Reference / catalog number

ED7043

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.

GS1

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.

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Product Content: ED7043-1 Stimulation Buffer ED7043-2 Stimulation Control ED7043-3 Staining Reagent ED7043-4 Lysing Solution One kit is sufficient for 100 tests.

Additional information URL

https://www.exbio.cz/clinical-products/allergy/kits/basoflowex-kit

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.

• W0103080699REAGENTS FOR FLOW CYTOMETRY - OTHER

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.