Organization name

Abbott Molecular Inc.

SRN

US-MF-000017776

Manufacturer status

Active

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

• H302 – Harmful if swallowed.
• H315 – Causes skin irritation.
• H317 – May cause an allergic skin reaction.
• H370 – Causes damage to organs.
• H412 – Harmful to aquatic life with long lasting effects.
• P260 – Do not breathe dust/fume/gas/mist/vapours/spray.
• P264 – Wash thoroughly after handling.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P308 – IF exposed or concerned: P311 – Call a POISON CENTER or doctor/physician.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P333 – If skin irritation or rash occurs: P362 – Take off contaminated clothing and wash before reuse.
• P364 And wash it before reuse.
• P302 – IF ON SKIN: P362 – Take off contaminated clothing and wash before reuse.
• P308 – IF exposed or concerned: P362 – Take off contaminated clothing and wash before reuse.
• P501 - Dispose of contents / container in accordance with local regulations.

  OTHER

• Consult instructions for use

Primary placement in Germany; available across 14 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.

00884999051249

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.

0884999AMN0041WA

Reference / catalog number

09N15-092

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 HR HPV 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.

• W0105041003PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
• W0105041002SCREENING HIGH-RISK HPV - NA REAGENTS

• IVDR Class C medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.