Organization name

CHROMagar™

SRN

FR-MF-000024723

Manufacturer status

Active

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

• Do not use if package is damaged
• Do not use past indicated date
• GHS08 - Danger or Warning - Systemic health hazards
• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• H317 – May cause an allergic skin reaction.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P284 – Wear respiratory protection.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.

Primary placement in France; available across 32 countries total.

Trade name

CHROMagar™ C.difficile supplement

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.

03760344760394

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.

376034476CD12S3J

Reference / catalog number

CD122(S)

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 A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Fluorogenic medium supplemùent for detection of Clostridioides difficile.

Additional information URL

http://www.chromagar.com/

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.

• W0104010104ADDITIVES FOR DCM (GROWTH SUPPLEMENTS, SELECTIVE AGENTS, ...)

• IVDR Class A medical devices in EUDAMED

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