FDA 510(k) Review Pending: FECAL TRANSWAB® with Liquid Cary Blair Medium

FECAL TRANSWAB® with Liquid Cary Blair Medium is currently under FDA 510(k) review. Discover how this globally used stool collection and transport system supports reliable microbiological testing with validated performance and room-temperature storage.
FDA 510(k) pending for MWE FECAL TRANSWAB

Advancing Reliable Transport for Fecal Specimens

The FECAL TRANSWAB® with Liquid Cary Blair Medium for Specimen Collection and Transport System is currently under FDA 510(k) review in the United States. Already adopted extensively across Europe, Asia, Australasia and by global healthcare organisations, this pending clearance represents the next step in supporting laboratories that routinely process fecal specimens for microbiological investigation.

Supporting High-Quality Stool Culture Workflows

Fecal testing remains central to diagnosing gastrointestinal infections caused by bacteria, parasites and other clinically relevant microorganisms. When samples are not transported effectively, laboratory recovery and patient outcomes can be compromised.

FECAL TRANSWAB® with Liquid Cary Blair Medium is designed to preserve the viability of fecal specimens after collection and during transportation to the laboratory. Samples can be collected directly from patients using the swab as a rectal swab or transferred from a stool sample using a standard laboratory workflow.

Practical Benefits for Transport and Storage

Room-temperature performance is of growing interest to laboratories and health systems seeking to reduce logistical costs. FECAL TRANSWAB® with Liquid Cary Blair Medium supports room-temperature transport and storage, with the option for refrigeration when required. Combined with a 24-month shelf life, the device offers workflow efficiency both inside and outside of the laboratory.

Looking Ahead

Pending FDA 510(k) clearance creates momentum for broader availability of FECAL TRANSWAB® with Liquid Cary Blair Medium in the United States. If approved, laboratories seeking reliable stool collection and transport solutions will gain access to a device already trusted internationally and supported by extensive validation data.

Medical Wire & Equipment (MWE) will announce and share further details upon completion of the review.

Get in touch with the MWE USA team for more information.
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