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Affymetrix® Gene Profiling Reagents

Take the faster, proven path to market with the first FDA-cleared, IVD, and CE-marked gene expression microarray reagent kit for diagnostic test development.

Product Description

Affymetrix® Gene Profiling Reagents are the first FDA-cleared, IVD, and CE-marked microarray reagents for use in the development and commercialization of separately cleared clinical diagnostic tests.

Affymetrix Gene Profiling Reagents enable diagnostic test developers to:

Intended Use Statement

For In Vitro Diagnostic Use

Affymetrix® Gene Profiling Reagents are intended for the preparation of labeled complementary RNA target from purified total RNA from fresh or frozen clinical tissue specimens for hybridization to Affymetrix GeneChip® microarrays and the measurement of fluorescence signals of labeled RNA target using the Affymetrix GeneChip Microarray Instrumentation System.

Manuals

Gene Profiling Assay - cGMP U133 P2 v1.1 Assay Software Module User's Guide (pdf, 912 KB)

Gene Profiling Reagents User Guide (pdf, 800 KB)

Quick Reference Cards

Gene Profiling Reagents (pdf, 130 KB)

Gene Profiling Reagents, DUTCH (pdf, 325 KB)

Gene Profiling Reagents, FRENCH (pdf, 335 KB)

Gene Profiling Reagents, GERMAN (pdf, 249 KB)

Gene Profiling Reagents, GREEK (pdf, 282 KB)

Gene Profiling Reagents, ITALIAN (pdf, 174 KB)

Gene Profiling Reagents, PORTUGUESE (pdf, 172 KB)

Gene Profiling Reagents, SPANISH (pdf, 182 KB)

Material Safety Data Sheets

Gene Profiling Reagents, RNA Control Kit (zip, 44 KB)

Gene Profiling Reagents, Transcript Detection Kit (zip, 284 KB)

Gene Profiling Reagents, Transcript Synthesis & Labeling Kit (zip, 108 KB)

Package Inserts

Gene Profiling Reagent Kit - RNA Control Kit (pdf, 173 KB)

Gene Profiling Reagent Kit - RNA Control Kit, DUTCH (pdf, 73.6 KB)

Gene Profiling Reagent Kit - RNA Control Kit, FRENCH (pdf, 78.8 KB)

Gene Profiling Reagent Kit - RNA Control Kit, GERMAN (pdf, 74.1 KB)

Gene Profiling Reagent Kit - RNA Control Kit, GREEK (pdf, 176 KB)

Gene Profiling Reagent Kit - RNA Control Kit, ITALIAN (pdf, 77.5 KB)

Gene Profiling Reagent Kit - RNA Control Kit, PORTUGUESE (pdf, 74.5 KB)

Gene Profiling Reagent Kit - RNA Control Kit, SPANISH (pdf, 74.7 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit (pdf, 215 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, DUTCH (pdf, 129 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, FRENCH (pdf, 135 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, GERMAN (pdf, 128 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, GREEK (pdf, 198 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, ITALIAN (pdf, 138 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, PORTUGUESE (pdf, 137 KB)

Gene Profiling Reagent Kit - Transcript Detection Kit, SPANISH (pdf, 137 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit (pdf, 207 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, DUTCH (pdf, 89.2 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, FRENCH (pdf, 90.6 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, GERMAN (pdf, 88.2 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, GREEK (pdf, 210 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, ITALIAN (pdf, 90.7 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, PORTUGUESE (pdf, 90.2 KB)

Gene Profiling Reagent Kit - Transcript Synthesis and Labeling Kit, SPANISH (pdf, 92.1 KB)

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