Organization name

Abbott Molecular Inc.

SRN

US-MF-000017776

Manufacturer status

Active

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

• H315 – Causes skin irritation.
• H317 – May cause an allergic skin reaction.
• H319 – Causes serious eye irritation.
• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• P302 – IF ON SKIN: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P304 – IF INHALED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P264 – Wash thoroughly after handling.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P284 – Wear respiratory protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P337 – If eye irritation persists: P313 – Get medical advice/attention.
• P342 – If experiencing respiratory symptoms: P311 – Call a POISON CENTER or doctor/physician.
• P333 – If skin irritation or rash occurs: P362 – Take off contaminated clothing and wash before reuse.
• P364 And wash it before reuse.
• P501 Dispose of contents / container in accordance with local regulations.

  OTHER

• H302 – Harmful if swallowed.
• H370 – Causes damage to organs.
• H412 – Harmful to aquatic life with long lasting effects.
• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P273 – Avoid release to the environment.
• P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P308 – IF exposed or concerned: P311 – Call a POISON CENTER or doctor/physician.
• P308 – IF exposed or concerned: P362 – Take off contaminated clothing and wash before reuse.
• P302 – IF ON SKIN: P362 – Take off contaminated clothing and wash before reuse.
• Consult instructions for use

Primary placement in Germany; available across 16 countries total.

Trade name

Alinity m

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.

00884999051010

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.

0884999AMN0024WA

Reference / catalog number

09N46-092

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 C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Alinity m CMV WB AMP Kit

Additional information URL

https://molecular.abbott/portal

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.

• W0105040205CMV - NA REAGENTS

• IVDR Class C medical devices in EUDAMED

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