CHROMID CARBA agar (CARB)

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

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

• • Ongoing Z-0839-2023 FDA Class II ·initiated 9 Nov 2022

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Trade Name

CHROMID® CARBA agar

Model / Reference

542202

Primary DI / UDI-DI

03573026600068

Basic UDI-DI

357302BUDI000131SS

510(k) Number

K181092 ↗

FDA Product Code

JSO

EMDN Code

W0104010402 Chromogenic id media (plates)

Device Class

Class A EUDAMED

Class II 510(k)

Regulation

21 CFR Part 866.1700

Market of Registration

France

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is CHROMID CARBA Agar specifically used for in a clinical microbiology lab?

  CHROMID CARBA Agar is designed to help identify carbapenemase-producing *Escherichia coli* and *Klebsiella pneumoniae* bacteria. It uses chromogenic substrates that create visible color changes in bacterial colonies, allowing for rapid differentiation of these resistant organisms from others. This aids in targeted treatment decisions for infections caused by these drug-resistant pathogens.

• How is CHROMID CARBA Agar supplied and prepared for use?

  The medium is supplied as a dehydrated powder, meaning it must be reconstituted in a laboratory setting before use. It is intended for single-use only and requires direct inoculation of rectal swab specimens onto the prepared agar—no prior enrichment is needed. The powder form ensures stability during storage and allows for easy preparation when needed.

• Is CHROMID CARBA Agar sterile, and how should it be stored?

  Since it is supplied as a dehydrated powder, sterility is achieved during the preparation process in the lab (e.g., using sterile water and aseptic technique). The powder itself is not sterile until reconstituted. Storage instructions are not explicitly detailed, but typical practice for dehydrated culture media suggests keeping it in a cool, dry place (e.g., 2–8°C) away from direct light to preserve its efficacy until use.

• Can this product be reused after a single test, or is it strictly for one-time use?

  CHROMID CARBA Agar is explicitly labeled for single-use only. Once inoculated and incubated, the medium is intended to be discarded to prevent cross-contamination and ensure accurate results. This aligns with standard microbiology practices for culture media to maintain reliability and safety.

• What regulatory pathways does CHROMID CARBA Agar follow, and how does that affect its use?

  The product is cleared under FDA 510(k) (K181092) as a Class II device (product code JSO) for antimicrobial susceptibility testing, and it complies with the In Vitro Diagnostic Regulation (IVDR) in the EU. This means it has undergone rigorous review by the FDA’s Microbiology (MI) advisory committee for safety and effectiveness, ensuring it meets established performance standards for identifying carbapenemase-producing bacteria in clinical settings.