INCELLDX, INC.

Address:1541 Industrial Road,San Carlos,CA,94070,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Reagents, Specific, Analyte (MVU) (4)

Premarket Exempt

Yes

Clear

Anti PD-L1 Antibody - B766C310500 Catalog Number : C31050

Device Description : Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated w Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647.

Device Class : 1

Duns Number: 833074623

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

HPV E6, E7 mRNA Probe - B766C311000 Catalog Number : C31100

Device Description : HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 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.

Device Class : 1

Duns Number: 833074623

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

Anti CD45 Antibody - B766U310750 Catalog Number : U31075

Device Description : Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoerythrin-Cyanine 7

Device Class : 1

Duns Number: 833074623

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

Anti Pan Cytokeratin Antibody - B766U311000 Catalog Number : U31100

Device Description : Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epit Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE).

Device Class : 1

Duns Number: 833074623

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

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