FDA Registration
Active
🇯🇴 Jordan
ATLAS MEDICAL
Reg #: 3007126977
·
FEI: 3007126977
·
Expires 2026
Products
18
Proprietary Names
38
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- ATLAS MEDICAL
- Registration Number
- 3007126977
- FEI Number
- 3007126977
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- King Abdullah Industrial Estate,, Sahab Free Zone Area P.O.Box 204
- City
- Amman Al 'Asimah
- Country
- JO
Regulatory Submissions
- 510(k) Number
- K102760
Owner / Operator
- Firm Name
- Atlas Medical
- Operator Number
- 10026421
- Address
- King Abdullah Industrial Estate,, Sahab Free Zone Area P.O.Box 204
- City
- Amman
- State
- Al 'Asimah
- Postal Code
- 11512
- Country
- JO
- Correspondent
- Raed S Shadfan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-12-23 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2014-03-06 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2024-12-23 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2012-05-20 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-12-23 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-10-07 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-10-07 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2024-12-22 |
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)
Atlas Home Liver Function Test (bilirubin, urobilinogen).
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)