Procise Stool Collection Kit

Organization name

ProciseDx Inc.

SRN

US-MF-000040747

Manufacturer status

Active

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

• H317 – May cause an allergic skin reaction.
• H412 – Harmful to aquatic life with long lasting effects.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P364 And wash it before reuse.

  P362+P364: Take off contaminated clothing and wash it before reuse.

Primary placement in France; available across 10 countries total.

Trade name

Procise Stool Collection Kit

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.

08100322949130

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.

081003229PDXE491222VJ

Reference / catalog number

4913

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

20

Additional product description

Each Procise Stool Collection Multipack Box (Ref 4913) contains twenty (20) Procise Stool Collection Kits (Ref 4912). The Procise Stool Collection Kit includes a proprietary specimen collection device and receptacle containing extraction buffer. The stool collection kit is designed for patient self-collection of a human stool sample containing an analyte to be measured on the ProciseDx Analyzer with specific Procise assays. The intended user for collection of the specimen is a patient, nurse or laboratory technician collecting a stool specimen. The intended user for the preparation of specimen for analysis using the ProciseDx System is a clinical laboratory, point-of-care, or physician’s office professional.

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.

• W05019001FAECES COLLECTION DEVICES

• IVDR Class A medical devices in EUDAMED

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