LifeSign Status DS Control Set - POS & NEG

LifeSign Status DS Control Set - POS & NEG
Key Features
  • SKU: LFS-21000
  • Condition: Factory New
  • Country of Origin: USA
  • Warranty: Not Available
  • Weight: 0.05 lb
  • Monitors the performance of detection methods of the Status DS Immunoassay (#20935), Status Nicotine Immunoassay (#21735), and Status Stik Assay
  • # of Tests: 2 x 5 ml
  • Used to assure that the reagents are working properly and that the assay procedure is followed correctly
  • It is recommended that a control be tested at regular intervals as good laboratory testing procedure and to follow federal, state, and local guidelines
  • This item is non-returnable

  • Learn more:

  • Purchasing Restriction: Medical license or prescription required
Contact The Manufacturer
  • MFR: LifeSign Ships from Manufacturer
  • MPN: 21000
  • Phone: (800) 526-2125
$109.89

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Description

The LifeSign Status DS Control Set - POS & NEG (#21000) is designed to monitor the performance of detection methods of the Status DS Immunoassay (#20935), Status Nicotine Immunoassay (#21735), and Status Stik Assay.

External quality controls may be used to assure that the reagents are working properly and that the assay procedure is followed correctly. It is recommended that a control be tested at regular intervals as good laboratory testing procedure and to follow federal, state, and local guidelines.

Note: Ships over ice. Refrigeration required upon receipt.

Specifications

LifeSign Status DS Control Set - POS & NEG Specifications

  • # of Tests: 2 x 5 ml.
  • Appearance:
    • Form: Liquid.
    • Color: Yellow.
  • Odor: Slight.
  • pH: 6 to 7.
  • Boiling Point: 100 °C.
  • Specific Gravity @ 20 °C: 1.005 to 1.025.

Literature

Frequently asked questions

What is included in the LifeSign Status DS Control Set?

The LifeSign Status DS Control Set includes two 5 ml vials: one positive control and one negative control. These controls are used to ensure the accuracy and reliability of immunoassays.

Which immunoassays does the LifeSign Status DS Control Set monitor?

The LifeSign Status DS Control Set is specifically designed to monitor the performance of detection methods for the following assays:

  • Status DS Immunoassay
  • Status Nicotine Immunoassay
  • Status Stik Assay

It ensures the accuracy of reagent function and verifies that the assay procedure is correctly followed, making it essential for quality control in lab settings.

Does using this control set help with regulatory compliance?

Yes, using the LifeSign Status DS Control Set aids in complying with federal, state, and local laboratory testing guidelines, ensuring your lab meets regulatory requirements.

Does this control set require strict refrigeration?

Yes, this product is temperature-sensitive and requires strict handling and storage to maintain its quality and efficacy for in vitro diagnostic use.

  • Required Temperature: Store at 2–8°C.
  • Handling: The control set ships over ice and must be refrigerated immediately upon receipt.

Following these guidelines ensures that the positive and negative controls function properly, allowing labs to reliably monitor the performance of Status DS, Nicotine, and Stik Assays.

What are the control solution specifications?

The control solutions are supplied as a yellow liquid with a slight odor. They are designed to be near-neutral, with a pH range of 6 to 7.

Key physical specifications include:

  • Specific Gravity (@ 20 °C): 1.005 to 1.025
  • Boiling Point: 100 °C

Additionally, the solution contains 0.1% Sodium Azide which serves as a preservative.

Does this set validate assay performance?

Yes, this control set is specifically designed for in vitro diagnostic use to monitor and validate the performance of certain LifeSign detection methods.

It serves as an essential quality control solution recommended for use at regular intervals to ensure:

  • Reagents are functioning properly.
  • Assay procedures are correctly followed, helping maintain regulatory compliance.

This control set monitors the performance of the following specific assays:

  • Status DS Immunoassay (#20935)
  • Status Nicotine Immunoassay (#21735)
  • Status Stik Assays

The set includes both Positive and Negative liquid controls (two 5 ml vials total). Please note that refrigeration (2–8°C) is mandatory for storage, and the product contains 0.1% Sodium Azide as a preservative.

Where is the LifeSign Status DS Control Set manufactured?

The LifeSign Status DS Control Set is manufactured in the USA.

Is this strictly for laboratory use?

Yes, this control set is intended strictly for professional use in a laboratory or clinical setting.

It is specifically designed for in vitro diagnostic use to monitor the performance of LifeSign’s Status DS, Status Nicotine, and Status Stik Assays. Using it is essential for quality assurance and compliance with federal, state, and local guidelines. This product is not intended for at-home use.

How does it ensure assay accuracy?

The LifeSign Status DS Control Set is crucial for quality control, as it helps:

  • Assure reagent function by verifying that the assay reagents are working correctly.
  • Verify correct procedure by confirming that the assay method is being followed accurately.
Is this product brand new?

Yes, this product is factory new, ensuring you receive a pristine and uncompromised control set for your laboratory needs.