OOVA, INC.

FDA Device Registration & Listing · New York, NY, US · Registration 3015867318

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
3015867318
FEI Number
3015867318
Entity Name
OOVA, INC.
City/State/Country
New York, NY, US
Establishment Address
335 Madison Avenue, New York, NY 10017, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Oova, Inc. (Owner Number: 10061273)
Owner / Operator Contact Address
335 Madison Avenue, New York, NY 10017, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Oova Hormone Kit Oova Fertility Hormone Kit Oova Perimenopause Hormone Kit Oova Fertility Hormone Kit Oova Hormone Kit Oova Perimenopause Hormone Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter Clinical Chemistry Class 1 862.1620 2024-12-31
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2019-10-03

Official Correspondent

Aparna Divaraniya

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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 3015867318. Last updated year: 2026. Please use registration number 3015867318 when referencing this establishment in official correspondence.
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