2SAN LLC

FDA Device Registration & Listing · New York, NY, US · Registration 3025041446

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
3025041446
FEI Number
3025041446
Entity Name
2SAN LLC
City/State/Country
New York, NY, US
Establishment Address
1330 Avenue of the Americas, New York, NY 10019, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
2San LLC (Owner Number: 10088220)
Owner / Operator Contact Address
1330 Avenue of the Americas, New York, NY 10019, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K182701
PMA Number
N/A

All Registered Proprietary Names

2San Vaginal pH Rapid Test Cassette 2San Urinary Tract Infection (UTI) Test Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test Speedy Swab Rapid COVID-19 Antigen Self-Test 2San Colorectal Cancer Test 2San Home Drug Test - 4 Panel 2San Home Drug Test - 7 Panel 2San Home Drug Test - 1 Panel (THC) 2San Home Drug Test - 14 Panel 2San Home Drug Test - 1 Panel (COC)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2023-06-12
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2024-01-10
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2024-01-10
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2024-10-23
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2023-06-12
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2023-06-12
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2023-06-12
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2023-06-12
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2023-06-12
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2023-06-12
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2023-06-12
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2023-06-12
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2023-06-12
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2023-06-12
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2023-06-12
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2023-06-12

Official Correspondent

Chelsea Tooze

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

2San LLC
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
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03
K162333 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14
K241741 Guangzhou Wondfo Biotech Co., Ltd. SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 2024-07-16
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-04 Instrumentation Laboratory Co. 1
Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025041446. Last updated year: 2026. Please use registration number 3025041446 when referencing this establishment in official correspondence.
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