RESIST-3 Carbapenemases rapid test

Organization name

Coris BioConcept

SRN

BE-MF-000024520

Manufacturer status

Active

Primary placement in Belgium; available across 32 countries total.

Trade name

RESIST-3 Carbapenemases rapid test

UDI-DI code

15420071900603

Basic UDI-DI

54200719K15R55R

Reference / catalog number

K-15R5

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

20

Additional product description

Rapid in vitro diagnostic medical device based on immunochromatography for the visual and qualitative detection of OXA-48, KPC, and NDM carbapenemases in bacterial culture (agar plate, blood or rectal swab), to aid in diagnostic of antimicrobial resistance mechanism in a hospitalized patients or individuals at risk of infection or colonization. For professional use only and not automated.

Additional information URL

https://www.corisbio.com/products/

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.

• W0104080506TARGETED RESISTANCE TESTS - CARBAPENEMASE