NOVODIAX, INC.

FDA Device Registration & Listing · Hayward, CA, US · Registration 3013043616

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013043616
FEI Number
3013043616
Entity Name
NOVODIAX, INC.
City/State/Country
Hayward, CA, US
Establishment Address
3517 Breakwater Ave, Hayward, CA 94545, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Novodiax, Inc. (Owner Number: 10053131)
Owner / Operator Contact Address
3517 Breakwater Ave., Hayward, CA 94545, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Q-STAIN X Autostainer ihc Blocker ihc Wash Buffer Kit (10x) ihc Magenta 1:1 Kit QSX Magenta QSX Blocker QSX Wash Buffer (10x) QSX-Enh-P PR QSX-Enh-P ER QSX-Enh-P HER-2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2022-02-04
PPM General Purpose Reagent Pathology Class 1 864.4010 2018-01-30
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2023-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Novodiax, Inc.
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 3013043616. Last updated year: 2026. Please use registration number 3013043616 when referencing this establishment in official correspondence.
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