Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2087033

FEI Number

3003102569

Entity Name

W.H.P.M., INC.

City/State/Country

Irwindale, CA, US

Establishment Address

5358 Irwindale Ave, Irwindale, CA 91706, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

W.H.P.M., INC. (Owner Number: 9042260)

Owner / Operator Contact Address

5358 Irwindale Ave, Irwindale, CA 91706, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DrugCheck SalivaScan Oral Fluid Drug Test; Origin Instant Drug Test; Origin Instant Oral Drug Test DrugCheck SalivaScan Oral Fluid Drug Test; Origin Instant Drug Test; Origin Instant Oral Drug Test DrugCheck SalivaScan Oral Fluid Drug Test; Origin Instant Oral Drug Test; Origin Instant Drug Test Origin Instant Drug Test; DrugCheck SalivaScan Oral Fluid Drug Test; Origin Instant Oral Drug Test Origin Instant Oral Drug Test; Origin Instant Drug Test; DrugCheck SalivaScan Oral Fluid Drug Test DrugCheck SalivaScan Oral Fluid Drug Test; Origin Instant Oral Drug Test; Origin Instant Drug Test DrugCheck NxScan OnSite DrugCheck NxStep OnSite Drug Test; DrugCheck Dip Drug Test; Origin Instant Drug Test DrugCheck Single Dip Drug Test; DrugCheck Single Dip Cassette Drug Test; CRLstat; ZeroChaos

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2025-03-06
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2002-02-23
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2025-03-06
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2005-08-31
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2005-08-31
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2005-08-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2005-08-31
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2005-08-31
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2005-08-31
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-10-16
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2014-12-18
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-04-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-04-20
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-04-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-04-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-04-20
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-04-20
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2025-03-06
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2025-03-06
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2025-03-06
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2014-04-02
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-04-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-04-20
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-10-16
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-04-20
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-04-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-04-20
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2025-03-06
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-10-16
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-10-16
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-10-16
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-10-16
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-10-16
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-10-16
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-04-20
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-04-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-04-20
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2002-02-23
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-03-06
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-03-06
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-03-06
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

W.H.P.M., 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
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
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11

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-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2087033. Last updated year: 2026. Please use registration number 2087033 when referencing this establishment in official correspondence.