Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042271096

FEI Number

3042271096

Entity Name

ANALYSIS OASIS GLOBAL LLC

City/State/Country

Newark, DE, US

Establishment Address

254 Chapman Rd Ste 208 #24748, Newark, DE 19702, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ANALYSIS OASIS GLOBAL LLC (Owner Number: 10094422)

Owner / Operator Contact Address

254 Chapman Rd Ste 208 #24748, Newark, DE 19702, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191924

PMA Number

N/A

All Registered Proprietary Names

Analysis Oasis Marijuana(THC) Urine Test Dip Card Analysis Oasis Marijuana(THC) Urine Test Strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2026-04-28
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2026-04-28
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2026-04-28
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-04-28

Official Correspondent

Faisal Almutairy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANALYSIS OASIS GLOBAL LLC

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
K896937	Hycor Biomedical, Inc.	HYCOR ACCUPINCH COCAINE TEST	1990-03-06
K915371	Diagnostic Reagents, Inc.	COCAINE METABOLITE EIA TEST	1991-12-18
K131754	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)	2013-07-31
K121166	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL	2012-05-08
K112071	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P	2011-09-23

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

Similar Registrations

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3008852306	Chemtron Biotech, Inc.	San Diego, CA, US
3009585529	ASSURE TECH. (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042271096. Last updated year: 2026. Please use registration number 3042271096 when referencing this establishment in official correspondence.