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Group 4

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 HealthBioAI website.

Group 47603 1

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.

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MOLECULE ILLU - WHITE

Products

 

IncellDX Product, Quality and Policy documents will be available within

the HealthBioAI website effective June 7, 2024. 

 

Please email us at info@incelldx.com for product information

 

 If you are a prospective patient looking for support with Chronic COVID, please visit
www.covidlonghaulers.com website.

To place an order call: +1.650.777.7630, email: orders@incelldx.com, or fax: +1.650.587.1528
(please include PO number, product number & quantity)

Group 2
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
 
Group 2
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
Group 2
INCELLPREP™ (IVD/CE-IVD) DESCRIPTION PRODUCT NUMBER TEST/KIT REGULATORY STATUS
incellPREP™ Tissue Single Cell Suspension System ifu incellPREP™ Homogenizers
incellPREP™ Sample Rack
incellPREP™ Battery Pack		 K17020
K15008
K17008		 20 preparations
1 Unit
1 Unit		 IVD/CE-IVD

 

ifu 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.

Group 2
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.

 

Group 2
INTERNATIONAL KIT CONFIGURATION DESCRIPTION PRODUCT NUMBER TEST/KIT REGULATORY STATUS

HPV OncoTect 3DxTM

CE-IVD Kit

*Available to limited geographies. Not available in the US and China. ifu

 HPV E6, E7 mRNA Kit D12100 100 tests ICE-IVD

 

ifu 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.

Group 2

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:

SGS_ISO_13485_round_TCL_HR

Employees certified in EU IVD-Regulation 2017-746