Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043196750

FEI Number

3043196750

Entity Name

KEVA INC.

City/State/Country

Blaine, WA, US

Establishment Address

2794 Peace Portal Dr Unit 130, Blaine, WA 98230, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Keva Inc. (Owner Number: 10094570)

Owner / Operator Contact Address

2794 PEACE PORTAL DR UNIT 130, Blaine, WA 98230, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MYCOPLASMA PNEUMONIAE TEST PHENCYCLIDINE TEST ADENOVIRUS ANTIGEN RAPID TEST ROTAVIRUS ANTIGEN RAPID TEST METHADONE TEST COCAINE TEST LH Ovulation Test MORPHINE TEST Human Chorionic Gonadotropin (HCG) Test Kit GROUP A STREPTOCOCCUS TEST FOLLICLE-STIMULATING HORMONE TEST Legionella Antigen Test CHLAMYDIA TRACHOMATIS TEST METHAMPHETAMINE TEST AMPHETAMINE TEST INFLUENZA A AND B TEST FENTANYL TEST OXYCODONE TEST KETAMINE TEST SALMONELLA TYPHI/PARA TYPHI ANTIGEN TEST HELICOBACTER PYLORI ANTIBODY TEST HELICOBACTER PYLORI ANTIGEN TEST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GSB	Antigens, Cf, All, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2026-02-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-02-26
GOB	Antigens, Ha (Including Ha Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2026-03-02
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-02-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-02-26
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2026-06-05
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2026-02-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2026-03-23
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2026-02-26
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-03-02
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2026-02-26
GPW	Antigen, Cf, Psittacosis (Chlamydia Group)	Microbiology	Class 1	866.3120	2026-02-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-02-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-02-26
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2026-02-26
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-03-02
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2026-03-02
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2026-02-26
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2026-02-26

Official Correspondent

Saying Mo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Keva 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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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3003917514	BTNX Inc.	Pickering Ontario, CA
3008741972	Lochness Medical	Buffalo, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043196750. Last updated year: 2026. Please use registration number 3043196750 when referencing this establishment in official correspondence.