HER2 Amplification FISH Detection Assay: Precise Diagnosis for Targeted Therapy

HER2 amplification FISH detection assay

Technology	FISH	ISH
HER2 amplification FISH detection assay
Area of interest	Formalin-fixed paraffin-embedded tissue sections or fixed cytological specimen	Formalin-fixed paraffin-embedded tissue sections or fixed cytological specimen
Region	17p11.1-q11.1	17p11.1-q11.1
	17q12	17q12
Detection	♦ (AF488, 2000) and ♦(AF555, 3000)	Biotin (0100) or Digoxigenin (9900)
Product No.	C801K.5206 (20T) or C801K.5206.05 or C801K.5206.10	C801K.0199.05 or C801K.0199.10
Product Type	In vitro diagnostics (IVD) or Research use only (RUO)	Research use only (RUO)
Intended Use	The REMBRANDT® HER2 amplification FISH detection assay is intended for the detection of amplifications of the Her2-neu gene (17q12 locus) compared to the chromosome 17 copy number status by means of fluorescence in situ hybridization in breast cancer patients.	The REMBRANDT® LSI17q12/CEP17 ISH detection assay is intended for the detection of copy numbers of the Her2-neu gene (17q12 locus) compared to the chromosome 17 copy number status by means of in situ hybridization.
Kit contents	C801P.5206 LSI 17q12/CEP17 FISH probe mix	C801P.0199.05 or C801P.0199.10 LSI 17q12/CEP17 ISH probe mix
	R018R.0000 Pepsin diluent	R018R.0000 Pepsin diluent
	R011R.0000 Pepsin powder	R011R.0000 Pepsin powder
	R025R.0000 PanWash 4, 25x SSC	R025R.0000 PanWash 4, 25x SSC
	R026R.0000 Pre-treatment buffer	R026R.0000 Pre-treatment buffer
	Z000R.0050 Fluorescent mounting medium

Catalog No.	HER2 amplification FISH detection assay

C801K.5206	REMBRANDT® HER2 amplification FISH detection assay
C801K.5206.05	REMBRANDT® HER2 amplification FISH detection assay
C801K.5206.10	REMBRANDT® HER2 amplification FISH detection assay
C801K.0199.05	REMBRANDT® LSI 17q12/CEP17 amplification ISH detection assay
C801K.0199.10	REMBRANDT® LSI 17q12/CEP17 amplification ISH detection assay

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