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GeneProof Ureaplasma PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • Enables the identification of Ureaplasma urealyticum using 3-channel system

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

CONTAMINATION PREVENTION

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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Ureaplasma PCR Kit UUP/ISEX/025 real-time PCR 25 reactions
GeneProof Ureaplasma PCR Kit UUP/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_UUP_QCMD_09_20_EN
pdf, [177.19 kB]
; GP_UUP_Instand_06_21_EN
pdf, [901.27 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative
Target Sequence UreD gene
Analytical Specificity

U. parvum, 100 %
U. urealyticum,100 %

Analytical Sensitivity (LoD) Reaches up to 0.687 cp/μl with the probability 95 % 
Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control

Validated Specimen

Swab, urine

Storage -20 ± 5 °C
Validated Extraction Methods

croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ Real-Time PCR Detection System *
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3 Real-Time PCR System *
QuantStudioTM 5 Real-Time PCR System
Rotor-Gene 3000 / Q
Rotor-Gene 6000 *
SLAN® Real-Time PCR System
StepOneTM / StepOne PlusTM Real-Time PCR System *

Required Detection Channels

FAM, HEX, Cy5

External Quality Assessment Regularly tested in QCMD External Quality Assessment panels – results at www.geneproof.com

* The device does not allow to distinguish between U. parvum and U. urealyticum.

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_UUP_Advisory_Notice_11_22_EN
pdf, [805.86 kB]
; GP_UUP_Instruction_for_Use_EN
pdf, [106.66 kB]

Declaration of Conformity

; GP_UUP_Declaration_of_Conformity_EN
pdf, [567.98 kB]

MSDS

; GP_UUP_Safety_Data_Sheet_EN
pdf, [275.45 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_Ureaplasma_Mic
micassay, [27.8 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_UUP_Leaflet_EN
pdf, [121.75 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
Files are available only for registered users.