Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030538

FEI Number

1000520007

Entity Name

Sekisui Diagnostics, LLC

City/State/Country

SAN DIEGO, CA, US

Establishment Address

6659 Top Gun St, SAN DIEGO, CA 92121, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sekisui Diagnostics, LLC (Owner Number: 10035388)

Owner / Operator Contact Address

6659 Top Gun Street, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033864

PMA Number

N/A

All Registered Proprietary Names

OSOM hCG Combo Test OSOM Card Pregnancy Test OSOM hCG Urine Test OSOM hCG Urine Control Set OSOM Strep A Test Rapidtesta RSV-Adeno Kit OSOM RSV/Adeno Kit EU RapidTesta RSV-Adeno Co.A 10T RapidTesta hs Adeno 10T RSV/Adeno Test (197E/198E) Sekisui Medical Adenovirus Dipstick (425868) Sekisui Medical RSV/Adeno Test (466588) OSOM RSV/ Adeno Control Kit OSOM RSV/ Adeno RapidTesta Ultra Strep A Co.A 10T RapidTesta Ultra Strep A 10T OSOM Trichomonas Control Kit OSOM Trichomonas Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSL	Control, Fecal Occult Blood	Hematology	Class 2	864.6550	2018-12-18
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2025-05-16
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2011-02-25
MXB	Test, Vaginal, Bacterial Sialidase	Microbiology	Class 1	866.2660	2011-02-25
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2011-02-25
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2011-02-25
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2020-03-31
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2016-11-17
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2012-12-27
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2019-03-19
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2019-02-19
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2018-12-18
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2011-02-25
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2017-06-15
OMG	Antisera, Fluorescent, Human Metapneumovirus	Microbiology	Class 2	866.3980	2019-01-07
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2017-06-15
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2018-12-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2018-12-18
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2011-02-25
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2016-07-26
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2019-07-10
JWZ	Kit, Screening, Trichomonas	Microbiology	Class 1	866.2660	2011-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sekisui Diagnostics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020316	Sekisui Diagnostics P.E.I. Inc.	CHARLOTTETOWN Prince Edward Island, CA
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
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
3005311019	ENTERIX PTY LTD.	NORTH RYDE New South Wales, AU
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US
3021010433	HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD	Hangzhou Zhejiang, CN
1226769	ENTERIX INC.	EDISON, NJ, US
3038371335	HEALGEN LIFE SCIENCE LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030538. Last updated year: 2026. Please use registration number 2030538 when referencing this establishment in official correspondence.