Rapidec Carba NP

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Model / Reference

415418

Primary DI / UDI-DI

03573026433659

Basic UDI-DI

357302BUDI000749UB

510(k) Number

K162385 ↗

FDA Product Code

PTJ

EMDN Code

W0104080506 Targeted resistance tests - carbapenemase

Device Class

Class B EUDAMED

Class II 510(k)

Regulation

21 CFR Part 866.1640

Market of Registration

France

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomerieux S.A. →

• What is the primary purpose of the Rapidec Carba NP in a clinical microbiology lab?

  The Rapidec Carba NP is designed to detect carbapenemase-producing organisms in cultured bacterial isolates, helping identify whether a pathogen exhibits non-susceptibility or elevated resistance to carbapenem antibiotics. This aids microbiologists in differentiating carbapenem-resistant pathogens, which is critical for guiding appropriate antimicrobial therapy and infection control measures.

• Is the Rapidec Carba NP intended for repeated use, or is it a single-use test kit?

  The Rapidec Carba NP is explicitly supplied as a single-use test kit. Each unit is intended for one analysis of cultured bacterial isolates, ensuring accuracy and preventing cross-contamination between samples. This aligns with standard microbiological practices for phenotypic resistance testing.

• How should the Rapidec Carba NP be stored, and are there any special handling requirements?

  Storage and handling follow standard microbiological practices, though specific conditions are not detailed in the provided data. As a single-use diagnostic device, it should be stored in a clean, dry environment protected from extreme temperatures and light until use. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain test integrity.

• What regulatory pathways does the Rapidec Carba NP follow, and how does this affect its use?

  The Rapidec Carba NP is cleared under FDA 510(k) (K162385) with a decision classification of *Substantially Equivalent* and complies with the EU In Vitro Diagnostic Regulation (IVDR). This means it has undergone regulatory review for safety and performance, ensuring its use in microbiology labs adheres to both U.S. and EU diagnostic standards. The classification as a Phenotypic Test Kit (device class 2) also reflects its role in identifying non-susceptible organisms.