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Description

Hardy Diagnostics HardyVal CSP Medium Complexity Microorganism Reproductive Health Test Kit

  • Quality culture media tested for performance, pH and sterility.
  • Kits are designed to help you follow USP <797> guidelines.
  • Kit performs one complete aseptic technique verification challenge test for one technician.

Frequently asked questions

Does this kit help maintain USP &lt;797&gt; compliance?
<p>Yes, the HardyVal CSP Medium Complexity Kit is specifically designed to assist healthcare and laboratory facilities in meeting the <strong>rigorous requirements of USP &lt;797&gt;</strong> regarding sterile preparations.</p>
Is the Tryptic Soy Broth quality-tested?
<p>Absolutely. The included culture media undergo <strong>rigorous testing</strong> for: - Performance accuracy - Correct pH levels - Guaranteed sterility for reliable results.</p>
How many technicians can one kit test?
<p>This kit is designed for a <strong>single-technician</strong> aseptic technique challenge, providing a comprehensive verification for one person per test.</p>
What specifically is included in the package?
<p>The kit is a complete set featuring: - <strong>3 Vials</strong> of 50 mL Tryptic Soy Broth (TSB) - <strong>6 Sterile</strong> 50 mL empty serum vials - <strong>3 Sterile</strong> 20 mL empty serum vials - <strong>1 Whirl-Pak</strong> bag - <strong>1 Results</strong> log sheet for documentation.</p>
Is this suitable for testing medium-risk compounding?
<p>Yes, it is perfectly tailored for <strong>medium-risk level compounding manipulations</strong>. It allows you to simulate complex transfers to validate that personnel are proficient in aseptic techniques.</p>
Are the testing materials BAA and TAA compliant?
<p>Yes, this kit is both <strong>Buy American Act (BAA) Compliant</strong> and <strong>Trade Agreement Act (TAA) Compliant</strong>, ensuring it meets high standards for domestic manufacturing.</p>
Is the result reading process straightforward?
<p>Yes, the kit utilizes a <strong>Visual Read</strong> format. This makes it efficient for microbiology quality control staff to assess aseptic skills without requiring complex instrumentation.</p>
Is this kit classified under CLIA regulations?
<p>No, the HardyVal CSP Medium Complexity Kit is categorized as <strong>Non-Regulated</strong> under CLIA classification, simplifying its integration into your laboratory’s existing quality control workflows.</p>