Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018126397

FEI Number

3018126397

Entity Name

VIVOSENS INC

City/State/Country

San Francisco, CA, US

Establishment Address

44 Tehama Street, Suite 409, San Francisco, CA 94105, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Vivosens Inc (Owner Number: 10085777)

Owner / Operator Contact Address

44 Tehama Street, Suite 409, San Francisco, CA 94105, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233624

PMA Number

N/A

All Registered Proprietary Names

Vivoo Vivoo LH Ovulation Test Vivoo Sediva Sedimentation Test Tube Vivoo Sediva Sedimentation Test Vivoo Vivoo hCG Pregnancy Test

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	2026-01-16
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-11-18
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2024-12-26
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2024-12-26
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	Class 1	864.6700	2024-12-26
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2026-01-16
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2026-01-16
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-11-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-11-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2024-11-18
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-11-18

Official Correspondent

Gozde Buyukacaroglu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vivosens 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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

Similar Registrations

Registration Number	Establishment Name	Location
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US
3007583565	SPD DEVELOPMENT COMPANY LIMITED	Bedford, GB
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018126397. Last updated year: 2026. Please use registration number 3018126397 when referencing this establishment in official correspondence.