Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• CW009

  Each single-use M10 Sputum Pretreatment Kit is used to process one test. Do not reuse used contents.
• CW010

  Please read Instructions carefully before you perform the test.
• CW007

  Do not use the test kit if the kit or kit component is damaged or the seal is broken.

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ M10 Sputum Pretreatment 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.

08800111718540

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.

88001117IPAA01MA11W5

Reference / catalog number

M10-SPTP-01/11PRT10A

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

10

Additional product description

STANDARD™ M10 Sputum Pretreatment Kit is used to liquefy and pretreat the sputum specimen before processing for downstream nucleic acid extraction and molecular diagnostic testing.

Additional information URL

http://www.sdbiosensor.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.

• W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.