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Charles River Endosafe:  Endotoxin Detection Products

Endotoxin Detection Products Endosafe - Click to follow 

Charles River Laboratories is a FDA-licensed manufacturer of Limulus Amebocyte Lysate (LAL) reagents and accessory products. LAL reagent is prepared from the circulating blood cells of the horseshoe crab (Limulus polyphemus). The facility location in Charleston, South Carolina provides for an abundant supply of horseshoe crabs and for the prompt return of specimens to their natural habitat. Endosafe® LAL is distributed throughout the world. In addition to traditional gel-clot LAL, Charles River provides a full range of quantitative LAL products utilizing novel colorimetric and turbidimetric assay systems.

The LAL assay is the most sensitive and specific means available to screen human drugs, biologics, animal drugs, medical devices and raw materials for the presence of harmful levels of endotoxin. Our optimized formulations provide increased sensitivity, greater linearity and superior interference-resistance qualities for our pharmaceutical and medical device customers.

GEL CLOT LAL  

The Gel Clot assay is a simple qualitative method best used for biologics and dialysis clinics and small, low volume laboratories. Endosafe lysate features a firm gel over a wide range of sensitivities. The reagent is buffered for better interference-resistance. 

KINETIC TURBIDIMETRIC LAL  

KTA is a test for quantitative endotoxin values when measured with a multi-tube or microplate reader adapted with endotoxin measuring software. Products available include KTA2, with faster reaction times and a wider standard curve range (.005-5.0 EU/ml), and KTA, a true gel clot LAL that permits a direct correlation to the gel clot assay. 

KINETIC CHROMOGENIC LAL 

Endochrome-K is a test for quantitative endotoxin values and contains a colorless substrate and LAL colyophilized into a single, stable reagent. The unique stability of our reconstituted LAL allows for extended bench time and 20°C storage and reuse. Multiple packaging options include a kit format or bulk packaging. 

ENDPOINT CHROMOGENIC LAL  

The endpoint chromogenic is a non-kinetic LAL assay that yields quantitative results quickly over a narrow standard curve range, without the need for an incubating plate reader. 

Our ISO certified, FDA licensed facility is equipped with state-of-the-art equipment and automated processes.

 Gel-Clot LAL Reagents

5.2 ml Vial Sensitivity Pack of 6 Case of 12 Box of 100
EU/ml Item Number Item Number Item Number
0.015 EN-R15015P EN-R15015C EN-R15015B
0.03 EN-R15003P EN-R15003C EN-R15003B
0.06 EN-R15006P EN-R15006C EN-R15006B
0.125 EN-R11012P EN-R11012C EN-R11012B
0.25 EN-R11025P EN-R11025C EN-R11025B

*AII sensitivities available in so Tests/Vial; 300 Tests/Pack; 600 Tests/Case; 5000 Test/Box.

1.2 ml Vial Sensitivity Pack of 6 Case of 12
  EU / ml Item Number Item Number
0.03 EN-R12003P EN-R12003C
0.06 EN-R12006P EN-R12006C
0.125 EN-R12012C EN-R12012C
0.25 EN-R12025P EN-R12025C

*AII sensitivities available in 10 Tests/Vial; 60 Tests/Pack; 12O Tests/Case.

0.2 ml Vial Sensitivity Pack of 25 Case of 50
  EU / ml Item Number Item Number
0.03 EN-R13003P EN-R13003C
0.06 EN-R13006P EN-R13006C
0.125 EN-R13012P EN-R13012C
0.25 EN-R13025P EN-R13025C

Kinetic Turbidimetric Analysis

  Sensitivity Pack of 6 Case of 12 Box of 100
  EU/ml Item Number Item Number Item Number
KTA 0.015 EN-R15015P EN-R15015C EN-R15015B
  0.03 EN-R15003P EN-R15003C EN-R15003B
  0.06 EN-R15006P EN-R15006C EN-R15006B
         
KTA^2   EN-R19000P EN-R19000C EN-R19000B

 Kinetic Chromogenic Analysis 

Endochrome-K Description Item Number
256 Test Kit   EN-R1708K
  8 - 3.2 ml Vials LAL  
2 - 10 ng Control Std. Endotoxin  
3 - 30 ml LAL Reagent Water  
   
LAL Reagent
320 Test Kit
  EN-R1710K
  10 - 3.2 Vials Endochrome-K LAL  
   
LAL Reagent
3200 Tests
  EN-R17100K
  100 - 3.2 ml Vials
Endochrome-K LAL
 

Endpoint Chromogenic Analysis

Endpoint Chromogenic Description Item Number   
  LAL Kit - 140 Tests EN-R160

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