HPV E6, E7 mRNA Probe C31100

GUDID B766C311000

HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a single transcript using a common promoter and early polyadenylation site. HPV E6, E7 mRNA Probe is comprised of a cocktail of 85% pure full-length dual fluorescein-labelled molecules as verified by Reverse Phase HPLC.

INCELLDX, INC.

Nucleic acid hybridization detection IVD, probe

• Primary Device ID: B766C311000
• NIH Device Record Key: 25ff6a99-dbc6-4f52-97bd-71ae15a87c8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HPV E6, E7 mRNA Probe
• Version Model Number: C31100
• Catalog Number: C31100
• Company DUNS: 833074623
• Company Name: INCELLDX, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 315 Microliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B766C311000 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-21
• Device Publish Date: 2019-09-19

Devices Manufactured by INCELLDX, INC.

• B766C313150 - HPV E6, E7 mRNA Probe, Ready to Use: 2023-03-08 HPV E6, E7 mRNA Probe, Ready to Use is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcr
• B766C310500 - Anti PD-L1 Antibody: 2020-02-13 Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647.
• B766U310750 - Anti CD45 Antibody: 2020-02-13 Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoerythrin-Cyanine 7
• B766U311000 - Anti Pan Cytokeratin Antibody: 2020-02-13 Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE).
• B766C311000 - HPV E6, E7 mRNA Probe: 2019-11-21HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a single transcript using a common promoter and early polyadenylation site. HPV E6, E7 mRNA Probe is comprised of a cocktail of 85% pure full-length dual fluorescein-labelled molecules as verified by Reverse Phase HPLC.
• B766C311000 - HPV E6, E7 mRNA Probe: 2019-11-21 HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a sing