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EC CERTIFICATE

EC Declaration of Conformity Annex (List B)

EC Declaration of Conformity Annex (Others)

CERTIFICATE ISO 13485

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

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

www.interlabservice.ru info@interlabservice.ru
+7 (495) 664 28 84
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Types, prepacking and packaging arrangment for PCR-diagnostics kits

Detection method: - FRT; - FEP; - EF; - HA
Packaging arrangement (PA): kits with all reagents for all PCR analysis steps ALL SET
kits with reagents for only one step of PCR-analysis PCR ONLY
Prepacking: PCR tubes with reaction mixture under wax layer
all reagents are in individual vials (no PCR-tubes)
all reagents are in individual vials (no PCR-tubes) + Taq-F polymerase ( hot start)

  All Set Kits
PCR analysis kits with complete set of reagents (DNA/RNA extraction,Reverse transcrip tion, Amplification and Detection Kits).

  Electrophoretic Detection of PCR products (EPh)
Labelling Number of tests, types of tubes Detection Method Descriptions Composition
**-100-R0,5 100 tests, tubes 0,5 ml Horizontal electrophoresis, UV transalluminator Amplification product separation on agaros gel with intercalated dye Include 3 or 4 kits:
1. Nucleic acids extraction Kit;
2. Reverse transcription Kit only for RNA viruses
3. DNA (cDNA) amplification Kit
4. Electophortic Detection Kit
**-100-R0,2 100 tests, tubes 0,2 ml
  end point analysis - FEP Fluorescence detection with End Point analysis
Labelling Number of tests, types of tubes Detection Method Descriptions Composition
T**-100-R0,5-FEP 100 ests, tubes 0,5 ml Fluorescence PCR detectors: ALA-1/4 (BioSan, Latvia); DGIN (-TECHNOLOGY, RUSSIA) Detection of fluorescence signal by the end point of PCR Include 2 or 3 kits:
1. Nucleic acids extraction Kit;
2. Reverse transcription Kit only for RNA viruses
3 DNA (cDNA) amplification Kit with fluorescence zonds
T**-100-R0,2-FEP 100 tests, tubes 0,2 ml
T**-50-R0,5-FEP 50 tests, tubes 0,5 ml
T**-50-R0,2-FEP 50 tests, tubes 0,2 ml
  Real Time analysis (Real-time PCR) - FRT Fluorescence Real-Time detection
Labelling Version Detection Method Descriptions Composition
TR-**- T() Quantitative analysis-ITR Thermocyclers with fluorescence detection in real time Measurements of fluorescence signal in progress of PCR in real Include 2 or 3 kits
1. Nucleic acids extraction kit;
2. Reverse transcription kit only for RNA viruses
3. DNA (cDNA) amplification in real time kit
TR-**- () Quantitative analysis ONITOR
TR-**- (RG) Rotor-Gene (Corbett Research, ustralia)
TR-**- (iQ) iQ iCycler (Bio-Rad, USA)
TR-**- (SC) SmartCycler (Cepheid, USA)
TR-**- (Mx) Mx3000P (Strategene, USA)
  Hybridization analysis (HA)
Method Labelling Version Detection Method Composition
Results detection by HA method TH-**-G-R0,5 Tubes 0,5 ml Qualitative analysis Microplates reader and incubator for microplates Include 3 or 4 kits:
1. Nucleic acids extraction kit;
2. Reverse transcription kit only for RNA viruses
3. DNA (cDNA) amplification kit
4. PCR-products detection by Hybridization analysis method kit
TH-**-G-R0,2 Tubes 0,2 ml
TH-**- M   Quantitative analysis
Immunosorbtion and Results detection by HA method TH-**-S-R0,5 Tubes 0,5 ml Qualitative analysis
TH-**-S-R0,2 Tubes 0,2 ml

  PCR Only Kits (Amplification only)
Included reagents only for amplification step or reverse transcription and amplification.

  Electrophoretic detection of PCR products (EPh)
Labelling Number of tests, types of tubes Detection Method Descriptions
**-200 220 tests (no prepacking) Horizontal electrophoresis , UV-transalluminator Amplification product separation on agaros gel with intercalated dye
**-100-R0,5 110 tests, tubed 0,5 ml
**-100-R0,2 110 tests, tubed 0,2 ml
  end point analysis - FEP Fluorescence detection with End Point analysis
Labelling Number of tests, types of tubes Detection Method Descriptions
**-100-R0,5-FEP 100 ests, tubes 0,5 ml Fluorescence PCR detector: ALA-1/4 (BioSan, Latvia); DGIN (-TECHNOLOGY, RUSSIA) Detection of fluorescence signal by theend point of PCR
**-100-R0,2-FEP 100 ests, tubes 0,2 ml
**-50-R0,5-FEP 50 ests, tubes 0,5 ml
**-50-R0,2-FEP 50 ests, tubes 0,2 ml
  Real Time analysis (Real-time PCR) - FRT Fluorescence Real-Time detection
Labelling Detection Method Descriptions
  Thermocycler with fluorescence detection in real time Measurements of fluorescence signal in progress of PCR in real
R-**- (RG)Rotor-Gene (Corbett Research, ustralia)
R-**- (iQ)iQ iCycler (Bio-Rad, USA)
R-**- (SC)SmartCycler (Cepheid, USA)
R-**- (Mx)Mx3000P (Strategene, USA)

** - special labeling according to infection cause agent.
Reagents for reverce transcription included only in case of RNA viruses