Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017772438

FEI Number

3017772438

Entity Name

Sekisui Diagnostics, LLC

City/State/Country

San Diego, CA, US

Establishment Address

6740 Cobra Way, San Diego, CA 92121, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K083746

PMA Number

N/A

All Registered Proprietary Names

OSOM Ultra Strep A Test OSOM hCG Serum Control Set OSOM Strep A Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2011-02-25
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2018-12-18
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2011-02-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2011-02-25
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2011-02-25
OSL	Control, Fecal Occult Blood	Hematology	Class 2	864.6550	2018-12-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2011-11-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-11-17
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2011-02-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2019-07-10
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2018-12-18

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
2030538	Sekisui Diagnostics, LLC	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
2024674	QUIDEL CORP.	SAN DIEGO, CA, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
9611882	SSI Diagnostica A/S	Hilleroed Hovedstaden, DK
3004635103	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017772438. Last updated year: 2026. Please use registration number 3017772438 when referencing this establishment in official correspondence.