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Safety Information

PYR0MATCELLS

Millipore

PyroMAT® cells

Cryopreserved MonoMac 6 cells for use in the Monocyte Activation Test (MAT) for Pyrogen testing, pkg of 2 vials

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About This Item

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

Agency

EP Chapter 2.6.30

Quality Level

feature

ready-to-use

packaging

pkg of 2 vials

manufacturer/tradename

PyroMAT®

application(s)

pharmaceutical
pyrogen testing

compatibility

configured for PyroMAT® System

shipped in

dry ice

suitability

pyrogenic bacteria

General description

The PYROMAT® system is a robust, easy-to-perform and ready-to-use solution for pyrogen testing, using the Monocyte Activation Test (MAT). The PYROMAT® cells are cryopreserved human monocytic cells from the Mono-Mac-6 cell line. They have been validated to be used for MAT.
The PyroMAT® System is based on the Mono-Mac-6 (MM6) cell line and uses Interleukin-6 (IL-6) as a read out.
PyroMATcells contains the crypreserved MonoMac 6 cells, 2 x 1 mL

Application

PYROMAT® cells is used to determine the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes. It is used to ensure the safety of parenteral pharmaceutical products and medical devices.

Features and Benefits

  • Cryopreserved ready-to-use monocytic cells
  • The only cell line validated and available for the Monocyte Activation Test
  • Expression of all the Toll-like Receptors responsible for pyrogen detection

Packaging

1 box of 2 vials, sufficient for 1 test

Components

2 vials of cryopreserved Mono-Mac-6 cells

Recommended products

To be used with PyroMAT kit (PYR0MATKIT), Reference standard endotoxin (144.161.0001), NEP controls (MATHKSA, MATFLAGELLIN)

Legal Information

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

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Skin Sens. 1

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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