QXDx BCR-ABL %IS Kit (IVD/CE-IVD)

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QXDx™ BCR-ABL %IS Kit


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TESTIMONIAL

“Bio-Rad’s Droplet Digital PCR System is a powerful platform for monitoring patients being treated for CML. The increased sensitivity and precision of multiplexed BCR-ABL1 measurements as compared to qPCR, along with direct absolute quantification in target copies and no standard curves, lends to the rationale for ddPCR use in routine laboratory testing.”

Niels Pallisgaard
Department of Pathology
Zealand University Hospital
Denmark

The QXDx BCR-ABL %IS Kit is a digital PCR test that monitors the p210 BCR-ABL major translocation in the peripheral blood of patients with Chronic Myeloid Leukemia (CML). The test is designed and run on Bio-Rad's QXDx Droplet Digital PCR System, enabling precise, highly sensitive quantification of nucleic acids.

Features and Benefits

  • Absolute quantification — eliminates the need for standard curves
  • Simplified and scalable workflow — flexibility to evaluate 8 to 48 samples per run in a workflow as simple as qPCR
  • Direct reporting on International Scale (%IS) and Molecular Response (MR) values — provides standardized interpreted output

The QXDx BCR-ABL %IS Kit can be used with either one of Bio-Rad’s digital PCR systems FDA-cleared for use in regulatory/in vitro diagnostics (IVD)* environments:

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*Legal Notice
This product and/or its use is covered by claims of U.S. patents, and/or pending U.S. and non-U.S. patent applications owned by or under license to Bio-Rad Laboratories, Inc. Purchase of the product includes a limited, non-transferable right under such intellectual property for use of the product for internal research and diagnostic purposes only. No rights are granted for use of the product for commercial applications of any kind, including but not limited to manufacturing, quality control, or commercial services, such as contract services or fee for services. Information concerning a license for such uses can be obtained from Bio-Rad Laboratories. It is the responsibility of the purchaser/end user to acquire any additional intellectual property rights that may be required.

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QXDx BCR-ABL %IS Kit

12005660
Pkg of 1, digital PCR test for montoring patients with Chronic Myeloid Leukemia (CML)

12005660 templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12005660_1558382314.xml 12005660 05/20/19 07:32 PM en_US true internet/product_SKU 2019-08-26 23:40:00 /default/main/bio-rad/STAGING AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE,AU,BD,BN,KH,CN,HK,IN,ID,JP,KR,MO,MY,FM,NP,NZ,PW,PG,PH,SG,SB,LK,TW,TH,TO,VU,VN,AL,DZ,AI,AM,AT,AZ,BH,BE,BA,BW,BG,BF,CM,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HU,IS,IE,IL,IT,JO,KZ,KE,XK,KW,LV,LB,LI,LT,LU,MK,MG,ML,MT,MQ,MU,MD,MS,MA,NL,NG,NO,OM,PK,PS,PL,PT,QA,RO,RU,ST,SA,SN,RS,SK,SI,ZA,ES,SE,CH,TZ,TG,TN,TR,UG,UA,AE,UK,UZ,VA,EH,YE templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12005660_1558382314.xml /default/main/bio-rad/WORKAREA/default jv8xq1lo 2019-05-20 19:58:35 true jv8xq1lo templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12005660_1558382314.xml LSR N /default/main/bio-rad en 05/21/29 09:57 AM 1565996401684 2019-08-26 23:40:00 /default/main/bio-rad/WORKAREA/default/templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12005660_1558382314.xml 12005660-qxdx-bcr-abl-kit 1 12005660 BCR-ABL percent IS Kit QXDx BCR-ABL %IS Kit Pkg of 1, digital PCR test for montoring patients with Chronic Myeloid Leukemia (CML) /webroot/web/images/lsr/products/amplification_pcr/sku_thumb/global/12005660_tn.jpg /webroot/web/images/lsr/products/amplification_pcr/sku_view/global/12005660_view.jpg preview fdejesu QXDx BCR-ABL %IS KIt The QXDx BCR-ABL %IS Kit is a digital PCR test intended to monitor patients with Chronic Myeloid Leukemia (CML). QXDx BCR-ABL %IS Kit, BCR-ABL %IS Kit, BCR-ABL, BCR-ABL CE-IVD Kit 05/20/19 07:32 PM 05/21/29 09:57 AM AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE,AU,BD,BN,KH,CN,HK,IN,ID,JP,KR,MO,MY,FM,NP,NZ,PW,PG,PH,SG,SB,LK,TW,TH,TO,VU,VN,AL,DZ,AI,AM,AT,AZ,BH,BE,BA,BW,BG,BF,CM,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HU,IS,IE,IL,IT,JO,KZ,KE,XK,KW,LV,LB,LI,LT,LU,MK,MG,ML,MT,MQ,MU,MD,MS,MA,NL,NG,NO,OM,PK,PS,PL,PT,QA,RO,RU,ST,SA,SN,RS,SK,SI,ZA,ES,SE,CH,TZ,TG,TN,TR,UG,UA,AE,UK,UZ,VA,EH,YE LSR /LSR/Amplification---PCR/Droplet-Digital-PCR-System N 0 <p>Use the FDA-cleared QXDx BCR-ABL %IS Kit, a digital PCR test intended to monitor patients with Chronic Myeloid Leukemia (CML), to track the p210 BCR-ABL major translocation in the peripheral blood of patients with CML. The test is designed and run on Bio-Rad's QXDx AutoDG Droplet Digital PCR System, enabling precise, highly sensitive quantification of nucleic acids.</p> <h2 class="descHeader">Features and Benefits</h2> <ul> <li>Absolute quantification &mdash; eliminates the need for standard curves</li> <li>High precision and accuracy &mdash; increased sensitivity with 2-well test per patient sample</li> <li>Simplified and scalable workflow &mdash; flexibility to evaluate 8 to 48 samples per run in a workflow as simple as qPCR</li> <li>Direct reporting on International Scale (%IS) and Molecular Response (MR) values &mdash; provides standardized interpreted output</li> <li>Sufficient reagents to process 96 samples or quality control specimens when run in 2 wells per sample.</li> </ul> <h2 class="descHeader">Product Contents</h2> <p>The QXDx BCR-ABL %IS Kit includes:</p> <ul> <li>QXDx BCR-ABL Primers &amp; Probes, 1 tube/250 &micro;L (12004581)</li> <li>QXDx Nuclease Free Water, 2 tubes/1500 &micro;L (12004586)</li> <li>QXDx 5x iScript&trade; Select Reaction Mix, 1 tube/500 &micro;L (12004569)</li> <li>QXDx 2x Supermix, 3 tubes/1000 &micro;L (12004572)</li> <li>QXDx iScript&trade; Advanced Reverse Transcriptase, 1 tube/125 &micro;L (12004571)</li> <li>QXDx RT Primers, 1 tube/500 &micro;L (12004582)</li> <li>QXDx BCR-ABL 0.1%IS, 2 tubes/50 &micro;L (12004585)</li> <li>QXDx BCR-ABL 10%IS, 2 tubes/50 &micro;L (12004588)</li> <li>QXDx BCR-ABL H-CTRL, 2 tubes/50 &micro;L (12004584)</li> <li>QXDx BCR-ABL L-CTRL, 2 tubes/50 &micro;L (12004583)</li> <li>QXDx BCR-ABL Neg-CTRL, 2 tubes/50 &micro;L (12004573)</li> <li>QXDx BCR-ABL %IS Kit IFU, CE-IVD, 1 tube (16006672)</li> </ul> <p>The QXDx BCR-ABL %IS Kit can be used with Bio-Rad's FDA-cleared QXDx AutoDG ddPCR System:</p> <ul> <li><a href="../product/qxdx-autodg-ddpcr-system">QXDx AutoDG ddPCR System</a>, requires QXDx AutoDG Consumable Pack&nbsp;(<a href="../sku/12001922-qxdx-autodg-consumable-pack">12001922</a>) and QXDx Droplet Reader Oil Pack (<a href="../sku/12002526-qxdx-droplet-reader-oil-pack">12002526</a>)</li> </ul> <h2 class="descHeader">Related Categories</h2> <ul> <li><a href="../category/digital-pcr">Digital PCR</a></li> <li><a href="../category/qxdx-products-for-vitro-diagnostics-ivd">QXDx Product Family</a></li> </ul> <h2 class="descHeader">Supporting Documents</h2> <ul> <li>QXDx BCR-ABL %IS Kit Flier</li> </ul> <h2 class="descHeader">Online Resources</h2> <p><a href="../applications-technologies/introduction-digital-pcr">Digital PCR</a></p> /webroot/web/html/lsr/products/amplification_pcr/sku_view/description/global 12005660-qxdx-bcr-abl-is-kit-desc.html /webroot/web/html/lsr/products/amplification_pcr/sku_view/description/global/12005660-qxdx-bcr-abl-is-kit-desc.html Storage 2198 &ndash;25&deg;C to &ndash;15&deg;C until expiration date printed on label 1 0 G-102US templatedata/internet/documentation/data/LSR/Literature/G-102US_1565046409.xml 12001922 templatedata/internet/product_SKU/data/en_US/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12001922_1499803939.xml 12002526 templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12002526_1499804036.xml 12001921 templatedata/internet/product_SKU/data/LSR/Amplification---PCR/Droplet-Digital-PCR-System/12001921_1500333285.xml false $6,000.00 false $ null false false true true false USD true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=12005660&quantity= false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=12005660&CartQuote=QT&quantity= 1357 false true false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=12005660&AddToDefaultWishList=true&quantity= 41116000 6000.00 12005660
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PX1 PCR Plate Sealer

1814000
PCR plate sealer, includes heat sealing instrument, plate support block that holds 96-well and 384-well plates, sealing frame, power cord

1814000 /templatedata/internet/product_SKU/data/LSR/Amplification---PCR/PX1-PCR-Plate-Sealer/181-4000_1347058737.xml 1814000 09/07/12 03:51 PM en_US true internet/product_SKU 2019-05-04 16:19:27 /default/main/bio-rad/STAGING AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA,VN templatedata/internet/product_SKU/data/LSR/Amplification---PCR/PX1-PCR-Plate-Sealer/181-4000_1347058737.xml /default/main/bio-rad/WORKAREA/default jc7v8od3 2017-11-14 07:07:38 true jc7v8od3 templatedata/internet/product_SKU/data/LSR/Amplification---PCR/PX1-PCR-Plate-Sealer/181-4000_1347058737.xml LSR N /default/main/bio-rad en 09/07/22 03:57 PM 1555975164502 2019-05-04 16:19:27 /default/main/bio-rad/WORKAREA/default/templatedata/internet/product_SKU/data/LSR/Amplification---PCR/PX1-PCR-Plate-Sealer/181-4000_1347058737.xml 1814000-px1-pcr-plate-sealer 1 1814000 PX1 PCR Plate Sealer PX1 PCR Plate Sealer PCR plate sealer, includes heat sealing instrument, plate support block that holds 96-well and 384-well plates, sealing frame, power cord PCR plate sealer, includes heat sealing instrument, plate support block that holds 96-well and 384-well plates, sealing frame, power cord /webroot/web/images/lsr/products/amplification_pcr/sku_thumb/global/PX1-PCR-Plate-Sealer-SKU-181-4000-thumb.jpg /webroot/web/images/lsr/products/amplification_pcr/sku_thumb/global/PX1-PCR-Plate-Sealer-SKU-181-4000-thumb.jpg ,VN Molly Gregg PX1 PCR Plate Sealer The PX1 PCR plate sealer includes the heat sealing instrument with power cord, a single plate support block that fits both 96- and 384-well plates, and a sealing frame to aid in heat sealing. 1814000, px1, pcr, plate, sealer, heat, sealing, instrument, real, time, real-time, qpcr, seal 09/07/12 03:51 PM 09/07/22 03:57 PM AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA,VN en LSR /LSR/Amplification---PCR/PX1-PCR-Plate-Sealer N 0 <p>Use the PX1 PCR Plate Sealer for consistent, uniform sealing across the entire plate, minimizing evaporation during cycling. The small-footprint heat sealer is compatible with a wide range of PCR plates and different types of films and foils.</p> <h2 class="descHeader">Features and Benefits</h2> <ul> <li>Ready to seal in less than 3 min</li> <li>Support block holds both 96-and 384 well plates</li> <li>Motorized drawer for insertion of plate and seal</li> <li>Touch-screen interface allowing single button modification of temperature and time</li> <li>Easy access to previously stored sealing protocols</li> </ul> <p>The intuitive touch-screen interface of the PX1 PCR Plate Sealer shows instrument status, platen temperature, protocol name, set temperature, and time. Sealing protocols can be stored and easily edited. The sealer can be programmed to automatically shut down after a user-defined period of idle time. Touching the display after shutdown will reactivate the display and the sealer will begin heating to the last set temperature.</p> <p>The semi-automated PX1 PCR Plate Sealer provides fast, consistent sealing, removing human variability and increasing reproducibility. Uniform sealing over the whole plate is particularly important for low-volume samples where small amounts of evaporation can have significant effect. In qPCR experiments, differential evaporation from wells can lead to large standard deviations in the number of quantification cycles (Cq).</p> <h2 class="descHeader">Product Components</h2> <ul> <li>Heat sealing instrument</li> <li>Plate support block for both 96- and 384-well plates</li> <li>Sealing frame</li> </ul> <h2 class="descHeader">Related Products</h2> <ul> <li>Optically Clear Heat Seals, for PCR and real-time PCR applications (<a href="/en-us/sku/1814030-optically-clear-heat-seal">1814030</a>)</li> <li>Permanent Clear Heat Seals, nonpeelable, nonpierceable clear seals for PCR, water bath cycling, and sample disposal (<a href="/en-us/sku/1814035-permanent-clear-heat-seal">1814035</a>)</li> <li><strong>Pierceable Foil Heat Seals </strong>for PCR and<a href="/en-us/product/qx200-droplet-digital-pcr-system"> QX200&trade; Droplet Digital&trade; PCR System</a> applications (<a href="/en-us/sku/1814040-pierceable-foil-heat-seal">1814040</a>)</li> <li><strong>Peelable Foil Heat Seals </strong>laminate/foil peelable seals for PCR and sample storage (<a href="/en-us/sku/1814045-peelable-foil-heat-seal">1814045</a>)</li> </ul> <h2 class="descHeader">Related Categories</h2> <ul> <li><a href="/en-us/category/pcr-plates">PCR Plates </a></li> <li><a href="/en-us/category/heat-sealing-films-foils">Heat Sealing Films and Foils </a></li> <li><a href="/en-us/category/thermal-cyclers-for-pcr">Thermal Cyclers </a></li> <li><a href="/en-us/category/real-time-pcr-detection-systems">Real-Time PCR Detection Systems </a></li> <li><a href="/en-us/category/digital-pcr">Digital PCR </a></li> </ul> <h2 class="descHeader">Supporting Documents</h2> <ul> <li>PX1 PCR Plate Sealer <a href="/webroot/web/pdf/lsr/literature/bulletin_10023997.pdf" target="_blank" rel="noopener noreferrer">Instruction Manual </a></li> <li>PX1 PCR Plate Sealer and Heat Sealing <a href="/webroot/web/pdf/lsr/literature/bulletin_6257.pdf" target="_blank" rel="noopener noreferrer">Consumables Brochure</a></li> </ul> <h2 class="descHeader">Online Resources</h2> <ul> <li><a href="javascript:openAjaxOverlay(&quot;/webroot/web/html/lsr/products/amplification_pcr/product_overlay/global/px1-heat-sealing-films-foils.html&quot;);">Suggested Heat Sealing Parameters</a></li> <li>Amplification Plastics and Reagents <a href="/webroot/web/pdf/lsr/literature/10022527.pdf" target="_blank" rel="noopener noreferrer">Selection Guide</a></li> <li><a href="/en-us/applications-technologies/qpcr-real-time-pcr">qPCR/Real-Time PCR </a></li> <li><a href="/en-us/applications-technologies/qpcr-instrumentation">qPCR Instrumentation</a></li> </ul> /webroot/web/html/lsr/products/SKUs 181-4000.html /webroot/web/html/lsr/products/SKUs/181-4000.html 1 0 false $4,058.00 false $ null true false true true false USD true true true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=1814000&quantity= false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=1814000&CartQuote=QT&quantity= 1339 false true false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=1814000&AddToDefaultWishList=true&quantity= 41106300 4058.00 1814000
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