IncellDx
SINGLE CELL DIAGNOSTICS
Multiplex RNA in situ Hybridization, Multiplex Protein Detection,
DNA/Cell Cycle, Simultaneously…in Every Cell.
Effective June 7, 2024, all IncellDX Product, Quality and Policy
Documents will be available within this HealthBio website.
Our Mission: IncellDx, Inc. is a single cell diagnostic company committed to advancing Precision Medicine by offering transformative diagnostic and prognostic clinical patient information based on an innovative technology platform that enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers by an alternative diagnosis
| RUO | GPR | ASR | CE-IVD | US-IVD |
|---|---|---|---|---|
| HPV Control Cells | Hybridization Core Reagents | HPV E6, E7 mRNA Probe, Ready-to-Use | HPV OncoTect 3Dx | incellPREP Sample Rack |
| BioINK | Hybridization Core Reagents (Bulk) | Anti PD-L1 Antibody | incellPREP Battery Pack | incellPREP Battery Pack |
| CMV mRNA Probe | Cell Cycle Dye | Anti CD45 Antibody | incellPREP Homogenizer | incellPREP Homogenizers |
| incellMAX | Anti Pan Cytokeratin | incellPREP Sample Rack | ||
| incellMAX C |
| PROBES | DESCRIPTION | PRODUCT NUMBER | TEST/KIT | REGULATORY STATUS |
|---|---|---|---|---|
| HPV E6, E7 mRNA Probe | HPV E6, E7 mRNA Probe, Ready-to-Use | C31315 | 315 uL | ASR |
| CMV mRNA Probe | CMV mRNA Probe | E21100 | 100 tests | RUO |
| GENERAL LABORATORY REAGENTS & CONTROLS | DESCRIPTION | PRODUCT NUMBER | TEST/KIT | REGULATORY STATUS |
|---|---|---|---|---|
| Hybridization Core Reagents | Core Reagents | F12100 | 100 tests | GPR |
| HPV Control Cells | Control Cells | C25018 | 1.8 mL | RUO |
| incellMAX™ | Fix/Permeabilizer | C65050 | 50 uses | GPR |
| incellMAX C | Fixative | C65001 | 1 L | GPR |
| Cell Cycle Dye | Reagent | C65000 | 1 mg | GPR |
| CytoStat triCHROME | Reagent | 6607017 | 50 Tests | IVD/CE-IVD |
| Anti PD-L1 Antibody | Antibody | C31050 | 50 Tests | ASR |
| Anti CD45 Antibody | Antibody | U31075 | 75 uL | ASR |
| Anti Pan Cytokeratin | Antibody | U31220 | 55 uL | ASR |
| INCELLPREP™ (IVD/CE-IVD) | DESCRIPTION | PRODUCT NUMBER | TEST/KIT | REGULATORY STATUS |
|---|---|---|---|---|
| incellPREP™ Tissue Single Cell Suspension System | incellPREP™ Homogenizers | K17020 | 20 preparations | IVD/CE-IVD |
| incellPREP™ Sample Rack | K15008 | 1 Unit | ||
| incellPREP™ Battery Pack | K17008 | 1 Unit |
This product’s instruction for use is distributed electronically. A key-code is provided on the label of the product.
Go to eifu.incelldx.com to download the instruction for use using the key-code.
| BIOINK™ (RUO) | DESCRIPTION | PRODUCT NUMBER | TEST/KIT | REGULATORY STATUS |
|---|---|---|---|---|
| BioINK™ | BioINK PD-L1 CTC Core Kit | T22004 | - | RUO |
This product is for research use only. Not for use in diagnostic procedures.
| INTERNATIONAL KIT CONFIGURATION | DESCRIPTION | PRODUCT NUMBER | TEST/KIT | REGULATORY STATUS |
|---|---|---|---|---|
| HPV OncoTect 3Dx™ | HPV E6, E7 mRNA Kit | D12100 | 100 tests | CE-IVD |
| CE-IVD Kit | ||||
| *Available to limited geographies. Not available in the US and China. |
This product’s instruction for use is distributed electronically. A key-code is provided on the label of the product.
Go to eifu.incelldx.com to download the instruction for use using the key-code.
IncellDX
The CEO of IncellDx has issued the following Quality Policy Statement:
IncellDx is committed to developing, manufacturing and distributing products that are of the highest quality available to our customers. To that end, we are committed to meeting or exceeding all applicable quality, regulatory and customer requirements. In order to achieve our objectives, the management team and all the employees at IncellDx are dedicated to improving the continued suitability and effectiveness of our quality management system.
Certificates:
