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EC Declaration of Conformity Annex (List B)

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InterLabService
20/13, b.2,
Sadovnicheskaya str.
Moscow, Russia, 115035

Phone: +7 (495) 664 2884
Fax: +7 (495) 664 2889

www.interlabservice.ru [email protected]
+7 (495) 664 28 84
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Company news

24.01.2023
Amplisens® PCR Kits for HCV and HBV quantification (viral load) and HCV and HBV genotyping are CE IVD certified now!!!

 AmpliSens® HBV-Monitor-L PCR kit  PCR kit (lyophilized) ,   AmpliSens® HCV-Monitor-L PCR (lyophilized)  ,  AmpliSens® HCV-genotype-FRT PCR kit,   AmpliSens® HBV-genotype-FRT PCR kit  –  are CE IVD certified now.  Now we have 2 type of  Product line of HBV and HCV kits – RUO  and CE IVD. 

AmpliSens® HBV-Monitor-L PCR kit 

AmpliSens® HBV-Monitor-L PCR kit (catalog number  H-4022-1-14-CE)  is an in vitro nucleic acid amplification test for quantitative detection of hepatitis B virus (HBV) DNA in biological material using real-time hybridization-fluorescence detection of amplified products. The material for PCR is DNA-samples extracted from blood plasma. Lyophilized form. CE IVD! 

AmpliSens® HCV-Monitor-L  PCR kit

AmpliSens® HCV-Monitor-L  PCR kit (catalog number  H-4002-1-14-CE)   is an in vitro nucleic acid amplification test for quantitative detection of hepatitis C virus (HCV) RNA in biological material using real-time hybridization-fluorescence detection of amplified products. The material for PCR is RNA-samples extracted from blood plasma. Lyophilized form. CE IVD! 

AmpliSens® HCV-genotype-FRT PCR kit 

AmpliSens® HCV-genotype-FRT PCR kit (catalog number  H-0256-1-3-CE)   is an in vitro nucleic acid amplification test for differentiation of hepatitis C virus (HCV) genotypes in the clinical material (peripheral blood plasma) using real-time hybridization-fluorescence detection of amplified products.  PCR kit variant FRT-g1-6 is intended to detect HCV genotypes 1a, 1b, 2, 3a, 4, 5a, and 6. Liquid ready-to-use form . CE IVD!

AmpliSens® HCV-genotype-FRT PCR kit is recommended for use after detection of hepatitis C virus RNA by AmpliSens® HCV-Monitor-L PCR kit. 

AmpliSens® HBV-genotype-FRT PCR kit 

AmpliSens® HBV-genotype-FRT PCR kit (catalog number  H-1982-1-3-CE)   is an in vitro nucleic acid amplification test for differentiation of hepatitis B virus (HBV) genotypes A, B, C and D in the clinical material (blood plasma) using real-time hybridization-fluorescence detection of amplified products.  Liquid ready-to-use form. CE IVD!

AmpliSens® HBV-genotype-FRT PCR kit is recommended to use after detection of hepatitis B virus DNA by AmpliSens® HBV-Monitor-L PCR kit.

 

For further information please contact to our sales office : [email protected]

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