Organization name

Veracyte, Inc

SRN

US-MF-000048711

Manufacturer status

Active

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

• Consult instructions for use

  Read Instructions for Use symbol + URL visible on label

• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.

  BL Buffer

• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.

  DNase I / Proteinase K

• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.

  BL Buffer

• P303 – IF ON SKIN (or hair): P353 – Rinse skin with water/shower.

  BL Buffer

• P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.

  BL Buffer

• Caution

  Symbol used to alert in the IFU

• Do not use past indicated date

  Warning linked to expiration date

• GHS05 -Danger or Warning -Corrosive cat. 1

  BL Buffer

• GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards

  BL Buffer

• GHS08 - Danger or Warning - Systemic health hazards

  DNase I / Proteinase K

• H302 – Harmful if swallowed.

  BL Buffer

• H312 – Harmful in contact with skin.

  BL Buffer

• H314 – Causes severe skin burns and eye damage.

  BL Buffer

• H318 – Causes serious eye damage.

  BL Buffer

• H319 – Causes serious eye irritation.

  DNase I / Proteinase K

• H332 – Harmful if inhaled.

  BL Buffer

• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.

  DNase I / Proteinase K

• H412 – Harmful to aquatic life with long lasting effects.

  BL Buffer

• EUH 032 – Contact with acids liberates very toxic gas.

  BL Buffer

• EUH 071 – Corrosive to the respiratory tract.

  BL Buffer

• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.

  BL Buffer / DNase I / Proteinase K

• P301 – IF SWALLOWED: P310 – Immediately call a POISON CENTER or doctor/physician.

  BL Buffer

• P273 – Avoid release to the environment.

  BL Buffer

• P280 – Wear protective gloves/protective clothing/eye protection/face protection.

  BL Buffer

• P284 – Wear respiratory protection.

  DNase I / Proteinase K

• P301 – IF SWALLOWED: P330 – Rinse mouth.

  BL Buffer

• P301 – IF SWALLOWED: P331 – Do NOT induce vomiting.

  BL Buffer

• P303 – IF ON SKIN (or hair): P310 – Immediately call a POISON CENTER or doctor/physician.

  BL Buffer

• P305 – IF IN EYES: P310 – Immediately call a POISON CENTER or doctor/physician.

  BL Buffer

• P342 – If experiencing respiratory symptoms: P311 – Call a POISON CENTER or doctor/physician.

  DNase I / Proteinase K

• H315 – Causes skin irritation.

  Proteinase K

Primary placement in Ireland; available across 31 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.

00850024414068

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.

0850024414FFPERNAEXXV

Reference / catalog number

550100

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

Kit of reagents intended for RNA extraction from formalin-fixed and paraffin-embedded human tissue sample. 10 extractions per kit.

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.

• W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

• IVDR Class A medical devices in EUDAMED

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