LifeSign Uricult CLED/EMB Urine Culture System (10 Tests)

The LifeSign Uricult CLED/EMB Urine Culture System provides rapid results, with colony counts available within 18–24 hours after the sample is collected and incubated. This fast turnaround time supports quicker patient management decisions.

Yes, the LifeSign Uricult CLED/EMB Urine Culture System is CLIA compliant (Clinical Laboratory Improvement Amendments).

This compliance specifically covers the process of reporting colony counts, making the system an appropriate, moderately complex diagnostic tool for licensed medical facilities evaluating urinary tract infections (UTIs).

The LifeSign Uricult CLED/EMB Urine Culture System provides exceptionally high accuracy. It demonstrates a 99% correlation rate when compared directly to standard laboratory culture plates, ensuring reliable presumptive identification of uropathogens.

The LifeSign Uricult CLED/EMB Urine Culture System kit provides everything necessary for performing 10 presumptive identification tests of uropathogens, although an appropriate incubator is required (sold separately).

Each package contains:

• 10 Urine culture-paddles
• Self-adhesive patient labels
• Package insert
• Colony density chart (used for visual reading of results)

Yes, the LifeSign Uricult system is designed for ease of use in professional clinical settings. It utilizes a straightforward, three-step culture-paddle method for the presumptive identification of uropathogens.

Simple Procedure:

1. Dip the culture paddle directly into the urine sample.
2. Incubate the paddle (Note: An external incubator, such as the LifeSign Cultura M Incubator, is required).
3. Visually Read the results using the included colony density chart.

This simple, visual-read process facilitates rapid patient management, delivering colony count results within 18 to 24 hours.

Yes, the LifeSign Uricult CLED/EMB Urine Culture System is designed for the presumptive identification of uropathogens and the culture-based detection of bacteriuria, offering high diagnostic value in an in-office setting.

Key benefits and specifications include:

• Exceptional Accuracy: This system demonstrates a 99% correlation rate when compared directly to standard laboratory culture plates.
• Rapid Results: Results for colony counts are typically available within 18 to 24 hours, enabling faster patient management.
• Comprehensive Media: It utilizes a CLED/EMB media combination suitable for detecting and identifying common urinary pathogens.
• Easy to Use: The format features a simple culture-paddle procedure: dip, incubate (an incubator is required), and visually read the results against the provided density chart.

Yes, an incubator is mandatory to properly perform the LifeSign Uricult culture method. It is essential for maintaining the specific temperature required to facilitate reliable bacterial growth on the CLED/EMB media, which ensures accurate results.

• Required Equipment: An appropriate incubator must be used (e.g., the LifeSign Cultura M Incubator #05866).
• Time to Results: Colony count results are typically available for visual reading within 18 to 24 hours after the incubation period.
• Note: The incubator itself is not included in this kit and must be acquired separately.

Yes, the LifeSign Uricult CLED/EMB Urine Culture System is designed strictly for professional use in clinical and laboratory environments. It is classified as a moderately complex testing system and is explicitly not an at-home test.

To ensure accurate and compliant use, medical facilities must adhere to the following requirements:

• Setting: Testing must be performed within a certified lab facility.
• Licensing: The procedure requires appropriate physician licensing.
• Equipment: An external incubator (such as the LifeSign Cultura M Incubator #05866) is mandatory to complete the test procedure and obtain results.
• Compliance: The system is CLIA compliant for reporting colony counts, making it a reliable diagnostic tool for evaluating urinary tract infections.

Yes, the LifeSign Uricult CLED/EMB system is strictly intended for professional use in clinical or laboratory settings. It is classified as a moderately complex diagnostic tool and is not designed for at-home testing.

Its use is subject to specific regulatory requirements:

• It requires physician licensing for operation and reporting.
• Testing must be conducted within a certified lab facility.
• The system is CLIA compliant for reporting colony counts, ensuring a high correlation (99%) to standard lab culture plates.

The LifeSign Uricult CLED/EMB Urine Culture System is designed to be used with urine samples.