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1.44154

Millipore

PyroDetect Kit

Reagents and Interleukin-1ß ELISA kit for Monocyte Activation test (MAT), for Pyrogen testing

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Synonym(s):
Pyrogen testing kit

Agency

EP Chapter 2.6.30

Quality Level

200

feature

ready-to-use

packaging

pkg of 1 kit

manufacturer/tradename

PyroDetect

application(s)

pharmaceutical
pyrogen testing

compatibility

configured for PyroDetect Systems

shipped in

ambient

storage temp.

2-8°C

suitability

pyrogenic bacteria

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This Item
1.44158LY0100PYR0MATKIT
PyroDetect Kit Reagents and Interleukin-1ß ELISA kit for Monocyte Activation test (MAT), for Pyrogen testing

Millipore

1.44154

PyroDetect Kit

PyroDetect Interleukin Standard Interleukin-1Beta standard for use in the Monocyte Activation Test (MAT) for Pyrogen testing

Millipore

1.44158

PyroDetect Interleukin Standard

Lysozyme Activity Kit sufficient for 100 tests

Sigma-Aldrich

LY0100

Lysozyme Activity Kit

PyroMAT® kit Reagents and Interleukin-6 ELISA kit for Monocyte Activation Test (MAT), for Pyrogen testing

Millipore

PYR0MATKIT

PyroMAT® kit

packaging

pkg of 1 kit

packaging

pkg of 1 vials

packaging

-

packaging

pkg of 1 kit

manufacturer/tradename

PyroDetect

manufacturer/tradename

PyroDetect

manufacturer/tradename

-

manufacturer/tradename

PyroMAT®

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

-

application(s)

pharmaceutical
pyrogen testing

compatibility

configured for PyroDetect Systems

compatibility

configured for PyroDetect System

compatibility

-

compatibility

configured for PyroMAT®

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

General description

PyroDetect Kit is a Monocyte Activation Test (MAT) for the detection of pyrogens. This test allows the determination of the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes.

Application

The PyroDetect Kit is used for the detection and quantification of the pyrogenic activity in pharmaceutical products to ensure their safety.

Features and Benefits

  • Ready-to-use kit
  • Greater product safety
  • Highly compatible
  • In vitro test with cryoblood
  • Reliable results
  • Regulatory recognition

Components

Each PyroDetect Kit contains:
  • Cell Culture Microplate for 96 microcultures, with lid - 1 plate
  • Cell Culture Medium - RPMI with L-Glutamine and HEPES - 50 mL
  • IL-1β Microplate - 12 strips of 8 wells each, coated with a monoclonal antibody specific for IL-1β - 1 plate
  • IL-1β Conjugate
  • Wash Buffer Concentrate
  • Color Reagent Α
  • Color Reagent Β
  • Stop Solution

Principle

The PyroDetect System uses cryopreserved human whole blood as a source of monocytes. The response to pyrogenic substances is determined by measurement of the Interleukin-1β (IL-1β) production. The ELISA (enzyme-linked immunosorbent assay) microplate in the PyroDetect System is precoated with an antibody specific for IL-1β. Interleukin molecules present in the culture supernatant, transferred from the blood cultures, are bound to the immobilized antibody.
The unbound substances are washed away, and an enzyme-linked polyclonal antibody specific for IL-1β is added. The IL-1β bound complex is then detected in a color reaction initiated by the addition of a suitable substrate. The efficiency of IL-1β production in the pyrogen reaction is calculated from the data of a photometrical quantification of the colored product by the enzymatic reaction in an ELISA reader.

Recommended products

PyroDetect Cryoblood (1.44155)
Reference Standard Endotoxin (1.44161)
NEP Control of HKSA (MATHKSA)
NEP Control of Flagellin (MATFLAGELLIN)

Pictograms

CorrosionExclamation mark
GHS05,GHS07

Signal Word

Warning

Hazard Statements

H290 - H317 - H412

Hazard Classifications

Aquatic Chronic 3 - Met. Corr. 1 - Skin Sens. 1

Storage Class Code

8A - Combustible, corrosive hazardous materials

WGK

WGK 2

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