Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009161685

FEI Number

3009161685

Entity Name

Advanced Cell Diagnostics, Inc.

City/State/Country

Newark, CA, US

Establishment Address

7707 Gateway Blvd, Suite 200, Newark, CA 94560, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Advanced Cell Diagnostics (Owner Number: 10051491)

Owner / Operator Contact Address

7707 Gateway, Newark, CA 94560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACD RNA ISH Probe HPV-6 ACD RNA ISH Probe (concentrate) HPV-33 ACD RNA ISH Probe (concentrate) HPV-31 ACD RNA ISH Probe (concentrate) HPV-11 ACD RNA ISH Probe UBC (Positive Control) ACD RNA ISH Probe PPIB (Positive Control) ACD RNA ISH Probe Albumin ACD RNA ISH Probe EBV ACD RNA ISH Probe Napsin A ACD RNA ISH Probe (concentrate) HPV-18 RNAscope ISH Probe SARS-CoV-2 ACD RNA ISH Probe TTF-1 (Thyroid Transcription Factor-1) ACD RNA ISH Probe DapB (Negative Control) ACD RNA ISH Probe CMV ACD RNA ISH Probe HPV-31 ACD RNA ISH Probe HPV-16 RNAscope ISH Probe IGLL5 RNAscope ISH Probe Kappa RNAscope ISH Probe Lambda BOND RNAscope® Protease BOND RNAscope® Detection Reagents-BROWN BOND-PRIME® RNAscope® Brown Detection System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2016-07-22
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2016-03-25

Official Correspondent

Bob Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Cell Diagnostics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009161685. Last updated year: 2026. Please use registration number 3009161685 when referencing this establishment in official correspondence.