PHASE DIAGNOSTICS

FDA Device Registration & Listing · Garden Grove, CA, US · Registration 3014022295

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
3014022295
FEI Number
3014022295
Entity Name
PHASE DIAGNOSTICS
City/State/Country
Garden Grove, CA, US
Establishment Address
10527 Garden Grove Blvd., Garden Grove, CA 92843, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PHASE Diagnostics (Owner Number: 10075679)
Owner / Operator Contact Address
10527 Garden Grove Blvd., Garden Grove, CA 92843, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INDICAID health Urine Collection Kit INDICAID COVID-19 IgM/IgG Rapid Test INDICAID health Sexual Health 2 Urine Collection

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2024-04-30
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-06-23
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2023-08-08

Official Correspondent

Ricky Chiu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PHASE 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 3014022295. Last updated year: 2026. Please use registration number 3014022295 when referencing this establishment in official correspondence.
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