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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

RELIABLE DIAGNOSTICS

  • Dual targeting prevents detection failures caused by the occurrence of mutations
  • 100% diagnostic sensitivity

HIGH SPECIFICTIY

  • The kit detects all known HCV genotypes 1-8
  • 100% diagnostic specificity

UNIQUE FALSE-NEGATIVE RESULTS CONTROL

  • Unique Internal RNA control construction
  • Controls the whole diagnostic process, including RNA extraction, reverse transcription, and PCR amplification

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 5th WHO International Standard NIBSC 14/150

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE1023IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name REF Technology Packaging
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/025 real-time PCR 25 reactions
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_HCVD_Leaflet_EN
pdf, [487.28 kB]
Choose all

EQA results

EQA results

; GP_HCVD_QCMD_4_2023_EN_01
pdf, [178.79 kB]
; GP_HCVD_croBEE_QCMD_4_2023_EN_01
pdf, [179.01 kB]
; GP_HCVD_INSTAND_3_2023_EN
pdf, [1.06 MB]
; GP_HCVD_Instand_03_22_EN
pdf, [1.06 MB]
; GP_HCVD_Instand_03_21_EN
pdf, [1.02 MB]
; GP_HCVD_QCMD_2020
pdf, [192.74 kB]
; GP_HCVD_QCMD_manual_2019_EN
pdf, [167.03 kB]
Choose all

Files are available only for registered users.

Declaration of Verification

; Declaration of Verification of the kits with medical devices
pdf, [2.53 MB]

Instructions for Use & Advisory Notice

Instructions for Use are for informative purposes only

; GP_HCVD_Advisory_Notice_05_22_EN
pdf, [550.66 kB]
; GP_HCVD_Instructions_for_Use_EN
pdf, [572.73 kB]
; GP_HCVD_Instructions_for_Use_ES
pdf, [368.52 kB]
; GP_HCVD_Instructions_for_Use_FR
pdf, [766.44 kB]
; GP_HCVD_Instructions_for_Use_IT
pdf, [433.74 kB]
; GP_HCVD_Instructions_for_Use_PT
pdf, [441.08 kB]
; GP_Quantitative PCR kits_Advisory Notice_04_2023_EN
pdf, [724.54 kB]

Declaration of Conformity

; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [58.14 kB]
; GP_HCVD_Declaration_of_Conformity_EN
pdf, [592.61 kB]
; GP_HCVD_EC Design Examination Certificate_EN
pdf, [336.18 kB]

MSDS

; GP_HCVD_Safety_Data_Sheet_EN
pdf, [278.39 kB]

PCR Template

; GP_HCVD_Mic
micassay, [13.09 kB]
; GP_HCVD_template_AmpliLAB
tlpi, [3.04 kB]
; GP_UNI_3CH_2CH_ABI7500
edt, [10.33 kB]
; GP_UNI_3CH_2CH_AriaMx
amxt, [3.64 kB]
; GP_UNI_3CH_2CH_CroBee
fqt, [4.9 kB]
; GP_UNI_BioRad
prcl, [1.33 kB]
; RG_UNI_2CH_3CH_4CH
ret, [13.83 kB]

Order

+420 543 211 679
sales@geneproof.com


Customer Support 

Send request
+420 730 176 222
support@geneproof.com


FAQ


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