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Safety Information

PYR0MATKIT

Millipore

PyroMAT® kit

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

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About This Item

UNSPSC Code:
41116129
eCl@ss:
32160606
NACRES:
NA.74

Agency

EP Chapter 2.6.30

Quality Level

400

feature

ready-to-use

packaging

pkg of 1 kit

manufacturer/tradename

PyroMAT®

application(s)

pharmaceutical
pyrogen testing

compatibility

configured for PyroMAT®

shipped in

ambient

storage temp.

2-8°C

suitability

pyrogenic bacteria

General description

The PYROMAT® System is a ready-to-use, in vitro solution for pyrogen testing, using the Monocyte Activation Test (MAT). It is based on the Mono-Mac-6 cell line and interleukin 6 (IL-6) read-out. The human monocytes that encounter pyrogens from contaminated sample, produce cytokines (IL-6), which can be detected with an enzyme-linked immunosorbent assay (ELISA). The kit contains the reagents needed to prepare the sample, perform the incubation with the monocytic cells, and the reagents needed for the ELISA detection.

Application

The PYROMAT® System is used to ensure the safety of parenteral pharmaceutical products and medical devices.

Features and Benefits

Ready-to-use kit

Components

  • 96-well plate, Endotoxin free water, RMPI culture medium
  • IL-6 ELISA kit and plate

Storage and Stability

2-8°C

Recommended products

To be used with PYROMAT® cells (PYR0MATCELLS), Reference standard endotoxin (144.161.0001), NEP controls (MATHKSA, MATFLAGELLIN) and IL6 control (PYR0MATIL6)

Legal Information

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany

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1.44161

Reference Standard Endotoxin, EDQM endotoxin standard for Monocyte Activation Test

PYR0MATIL6

PyroMAT® Interleukin IL-6 standard, Interleukin-6 standard for use in the Monocyte Activation Test (MAT) for Pyrogen testing

MATFLAGELLIN

NEP Control Flagellin- PyroMAT® System MAT, Non-endotoxin pyrogen control of flagellin for use in monocyte activation test

MATHKSA

NEP Control HKSA- PyroMAT® System MAT, Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test

MATRESIQUIM0D

Resiquimod Non-Endotoxin Pyrogen (NEP) Control, for use with PyroMAT®

MATFSL1

FSL-1 Non-Endotoxin Pyrogen (NEP) Control, for use with PyroMAT®

MATPAM3CSK4

PAM3CSK4 Non-Endotoxin Pyrogen (NEP) Control, for use with PyroMAT®

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Signal Word

Danger

Hazard Classifications

Aquatic Chronic 2 - Eye Irrit. 2 - Met. Corr. 1 - Repr. 1B - Skin Irrit. 2 - Skin Sens. 1

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

PYR0MATKIT:

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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