HealthBio, Inc

FDA Device Registration & Listing · Hayward, CA, US · Registration 3008272746

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
3008272746
FEI Number
3008272746
Entity Name
HealthBio, Inc
City/State/Country
Hayward, CA, US
Establishment Address
30920 Huntwood Avenue, Hayward, CA 94544, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
HealthBio, Inc. (Owner Number: 10031342)
Owner / Operator Contact Address
30920 Huntwood Avenue, Hayward, CA 94544, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HPV E6, E7 mRNA Probe, Ready to Use_C31315 Hybridization Core Reagent 4, 200275 Cell Cycle Dye C65000 Hybridization Core Reagent 2, 200273 Hybridization Core Reagent 6, 200276 Hybridization Core Reagent 3, 200274 Hybridization Core Reagent F12100 Hybridization Core Reagent 7, 200277 Hybridization Core Reagent 1, 200272

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2010-01-22
PPM General Purpose Reagent Pathology Class 1 864.4010 2011-10-18

Official Correspondent

Pradeep Kumar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HealthBio, 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 3008272746. Last updated year: 2026. Please use registration number 3008272746 when referencing this establishment in official correspondence.
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