Incelldx Inc FDA Filings

FDA Registration(s)

Registration Number	3008272746
FEI Number	3008272746
Name	INCELLDX, INC
Owner & Operator	IncellDx
Contact Address	1541 Industrial Road San Carlos CA 94070 US
Official Correspondent	Janvi Chokshi x-650-5674958-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1541 Industrial Road San Carlos, CA 94070 US
Establishment Type	Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198

Device Company	Device	Date
GUDID B766C313150 INCELLDX, INC.	HPV E6, E7 mRNA Probe, Ready to Use	2023-03-08
GUDID B766U311000 INCELLDX, INC.	Anti Pan Cytokeratin Antibody U31100	2020-02-13
GUDID B766U310750 INCELLDX, INC.	Anti CD45 Antibody U31075	2020-02-13
GUDID B766C310500 INCELLDX, INC.	Anti PD-L1 Antibody C31050	2020-02-13
GUDID B766C311000 INCELLDX, INC.	HPV E6, E7 mRNA Probe C31100	2019-11-21
LEC INCELLDX, INC [IncellDx]	incellPREP	2017-01-05
PPM INCELLDX, INC [IncellDx]	OncoTect iO Control Cells C65010	2011-10-18
PPM INCELLDX, INC [IncellDx]	IncellMAX C65050	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent F12100	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 7, 200277	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 6, 200276	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 4, 200275	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 3, 200274	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 2, 200273	2011-10-18
PPM INCELLDX, INC [IncellDx]	Hybridization Core Reagent 1, 200272	2011-10-18
PPM INCELLDX, INC [IncellDx]	Cell Cycle Dye C65000	2011-10-18
MVU INCELLDX, INC [IncellDx]	HPV E6, E7 mRNA Probe_C31100	2010-01-22
MVU INCELLDX, INC [IncellDx]	Anti Pan Cytokeratin Antibody_U31100	2010-01-22
MVU INCELLDX, INC [IncellDx]	Anti PD-L1 Antibody_C31050	2010-01-22
MVU INCELLDX, INC [IncellDx]	Anti CD45 Antibody_U31075	2010-01-22