ATLAS MEDICAL

FDA Device Registration & Listing · Amman Al 'Asimah, JO · Registration 3007126977

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
3007126977
FEI Number
3007126977
Entity Name
ATLAS MEDICAL
City/State/Country
Amman Al 'Asimah, JO
Establishment Address
King Abdullah Industrial Estate,, Sahab Free Zone Area P.O.Box 204, Amman Al 'Asimah 11512, JO
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Atlas Medical (Owner Number: 10026421)
Owner / Operator Contact Address
King Abdullah Industrial Estate,, Sahab Free Zone Area P.O.Box 204, Amman, JO-AM 11512, JO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191099
PMA Number
N/A

All Registered Proprietary Names

Atlas Albumin Home Test Atlas Ovulation Test Midstream Test Atlas Ketone Home Test Atlas Home Pregnancy Test - Midstream Format Atlas Home Urinary Tract Infection (Leukocyte, Nitrite). Atlas Homne Urinary Tract Infection (Leukocyte, Nitrite). Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Nortriptyline) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Cannabinoids (THC)) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Oxycodone) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Cannabinoids (THC)) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Benzodiazepines) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Methadone) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Morphine) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Amphetamines) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Propoxyphene) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Phencyclidine (PCP)) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Cocaine metabolites) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methadone) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Propoxyphene) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methylenedioxymethamphetamine (MDMA)) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Morphine) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Methylenedioxymethamphetamine (MDMA)) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Benzodiazepines) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Amphetamines) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Buprenorphine) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Buprenorphine) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Oxycodone) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Secobarbital) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Secobarbital) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Phencyclidine (PCP)) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Cocaine metabolites) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Methamphetamines) American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methamphetamines) American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card (Nortriptyline)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2024-12-23
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2014-03-06
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2024-12-23
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2012-05-20
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2024-12-23
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2019-10-07
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2019-10-07
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2019-10-07
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-10-07
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2019-10-07
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2019-10-07
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2019-10-07
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2019-10-07
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2019-10-07
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2019-10-07
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2019-10-07
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-10-07

Official Correspondent

Raed Shadfan

US Agent Details

Neveen SHADFAN Email: neveenwork@hotmail.com Phone: (619) 6096698

Related Public Records

Same Entity

Atlas Medical
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
K885053 Biotrol, USA, Inc. BIOTROL URINE PROTEINS REAGENT 1989-01-30
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

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
Z-2787-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007126977. Last updated year: 2026. Please use registration number 3007126977 when referencing this establishment in official correspondence.
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