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ENDONEXT™ EndoZyme® II Go Strips ST - Recombinant Factor C Endotoxin Detection Assay

  • Regulatory status:RUO
Cat. No. Size Price


New 424107 216 tests
New 424109 1152 wells
Product Details
Technical Data

Description

ENDOZYME® II GO STRIPS contain all of the benefits of ENDOZYME® II GO with simple and consistent use due to the CSE pre-coated wells, with the flexibility to test anywhere from 1 to 21 samples with minimal waste. Laboratories do not always have 20 samples to fill a full plate; ENDOZYME® II GO STRIPS are designed with flexibility in mind—flexible number of samples and flexible testing timing. ENDOZYME® II GO STRIPS eliminate the need for vortexing, mixing, diluting, or adding of Control Standard Endotoxin (CSE) to achieve standard curve and Positive Product Controls (PPC). By significantly reducing handson time, ENDOZYME® II GO STRIPS not only make your lab more efficient, they reduce the risk of invalid results by eliminating manual preparation steps that can be prone to handling errors.

Shipping

At ambient temperature. Upon receipt, store the product at the temperature recommended below.

Storage/Expiration

Store the kit at 2–8°C. Under these conditions, assay components are stable till the expiry date is over. (See the expiry date indicated on the kit label).

Calibration Range

0.005 - 5 EU/mL

Limit of Detection

0.005 EU/mL

Summary

Features

EndoZyme® II Features:

  • Horseshoe Crab-free method relying on sustainable resources
  • State-of-the-art sensitivity (0.005 EU/mL) and assay range
  • Endotoxin-specific, no false-positive results from β-Glucans
  • Excellent lot-to-lot reproducability
  • Stable liquid reagents enabling flexibility in use
  • Follows BET methodology and validated according to the same criteria as conventional methods
  • Accepted by the FDA and included in the European Pharmacopoeia Chapter 5.1.10 since 2016

EndoZyme® II Go Benefits:

  • Assay run time: 20 minutes (0.05 EU/mL), 60 minutes (0.005 EU/mL)
  • Preloaded microplate eliminates manual preparation of standard dilutions and PPCs-
  • Over 50% reduction in handling time compared to conventional microplate assays
  • Significantly reduces risk of handling error during preparation steps
  • Higher precision and rate of valid results
  • Ideal for in-process control of water and raw materials, as well as product release testing
  • Ideal for automation and parallel processing of plates

Summary

ENDONEXT™ EndoZyme® II is a fluorescence end-point assay intended for quantitative determination of endotoxin (chemically lipopolysaccharide, LPS) in pharmaceutical end-products, in-process control and research samples, and medical device testing.

The rapid GO version of EndoZyme® II features GOPLATE™ - a microplate pre-filled with dried Control Standard Endotoxin, standard curve 0.005 - 50 EU/ml and Positive Product Controls (PPC) 0.5 EU/ml, all in duplicate replicates fulfilling pharmacopoeia standard curve requirements.

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