OMEGA LABORATORIES, INC.

FDA Device Registration & Listing · MOGADORE, OH, US · Registration 3004847291

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
3004847291
FEI Number
3004847291
Entity Name
OMEGA LABORATORIES, INC.
City/State/Country
MOGADORE, OH, US
Establishment Address
400 N CLEVELAND AVE, MOGADORE, OH 44260, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
OMEGA LABORATORIES, INC. (Owner Number: 9074072)
Owner / Operator Contact Address
400 NORTH CLEVELAND, --, Mogadore, OH 44260, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Druglizer LE5 Drug Tester System Omega Laboratories Hair Drug Screening Assay HAIR COLLECTION KIT Druglizer LE5 Drug Tester System Omega Laboratories Hair Drug Screening Assay Alcolizer LE5 Alcohol Tester Drugalizer LE5 Drug Tester System Druglizer LE5 Drug Tester System Omega Laboratories Hair Drug Screening Assay Omega Laboratories Hair Drug Screening Assay Omega Laboratories Hair Drug Screening Assay Omega Laboratories Hair Drug Screening Assay Druglizer LE5 Drug Tester System Alcolizer LE5 Alcohol Tester

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2019-10-04
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-11-19
MPQ Container, Specimen, Urine, Drugs Of Abuse, Over The Counter Pathology Class 1 864.3260 2005-11-16
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2019-10-04
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2019-11-19
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2019-10-04
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2019-10-04
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2019-11-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-11-19
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2019-11-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-11-19
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2019-10-04
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2019-10-04

Official Correspondent

Bill Corl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMEGA LABORATORIES, 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
K112236 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST 2011-09-19
K970265 Drial Consultants, Inc. ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST 1997-04-08
K051161 Quest Diagnostics, Inc. QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) 2005-11-22
K122904 Guangzhou Wondfo Biotech Co., Ltd. WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; 2012-11-15
K121987 Guangzhou Wondfo Biotech Co., Ltd. WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST 2012-08-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. 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 3004847291. Last updated year: 2026. Please use registration number 3004847291 when referencing this establishment in official correspondence.
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