QUANOVATE TECH INC.

FDA Device Registration & Listing · San Ramon, CA, US · Registration 3013501873

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
3013501873
FEI Number
3013501873
Entity Name
QUANOVATE TECH INC.
City/State/Country
San Ramon, CA, US
Establishment Address
111 Deerwood Rd Ste 200, San Ramon, CA 94583, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Quanovate Tech Inc. (Owner Number: 10054431)
Owner / Operator Contact Address
111 Deerwood Road, Suite 200, San Ramon, CA 94583, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mira Pregnancy Test Mira Ultra4 Wand Mira Plus Wand Mira Max Wand Mira Ultra4 Wand Mira Confirm Wand Mira Max Wand Mira Basal Body Thermometer Mira Ovum Wand Mira Ultra4 Wand

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-12-19
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2025-12-19
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2022-03-22
QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter Clinical Chemistry Class 1 862.1620 2021-03-10
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2023-02-03
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2022-06-09

Official Correspondent

Zheng Yang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Quanovate Tech Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013501873. Last updated year: 2026. Please use registration number 3013501873 when referencing this establishment in official correspondence.
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