FDA Registration
Active
🇺🇸 United States
PREGMATE LLC
Reg #: 3013679502
·
FEI: 3013679502
·
Expires 2026
Products
27
Proprietary Names
57
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- PREGMATE LLC
- Registration Number
- 3013679502
- FEI Number
- 3013679502
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3804 N 29th Ave
- City
- Hollywood
- State
- FL
- ZIP
- 33020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150022
Owner / Operator
- Firm Name
- PREGMATE LLC
- Operator Number
- 10055200
- Address
- 2268 ANCHOR CT
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33312
- Country
- US
- Correspondent
- VIKTAR MAROZAU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2023-02-03 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-02-03 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2018-01-30 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2017-06-19 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2017-06-19 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2017-06-19 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2017-06-19 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2018-01-30 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2026-01-21 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2018-01-30 |
Proprietary Names
True Level Urinalysis Test
PREGMATE Urinalysis Test
True Level Urinary Protein Test Strips
PREGMATE Urinary Protein Test Strips
Pregmate Ovulation and Pregnancy Test Strips
Pregmate Pregnancy Test
Pregmate Pregnancy Test Strips
TRUE LEVEL Drug Test
TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit
TRUE LEVEL Instant Drug Test
TRUE LEVEL Multi-Drug Testing Kit
PREGMATE Ovulation LH Test
True Level Ovulation LH Test
TRUE LEVEL Drug Screen Test Kit Dip Card
True Level Urinary Tract Infection UTI Test
True Level Urine Leukocyte Test
Pregmate Urine Leukocyte Test
Pregmate Urinary Tract Infection UTI Test
PREGMATE PH Test Strips
True Level PH Test Strips
Pregmate Ovulation Midstream Test
Pregmate Ovulation Test
Pregmate Ovulation Test Strips
EZ Level Ovulation Test Strips
EZ Level Ovulation Test
TRUE LEVEL Ketone Test Strips
PREGMATE Ketone Test Strips
True Level Urinary Urobilinogen Test Strips
Pregmate Urinary Urobilinogen Test Strips
PREGMATE Pregnancy HCG Midsream Test
PREGMATE One Step Urine Pregnancy HCG Test
PREGMATE Pregnancy HCG Test Strips
True Level Urine Ascorbic Acid Test Strips
Pregmate Urine Ascorbic Acid Test Strips
EZ Level Multi-Drug Testing Kit
EZ Level At Home Urine Drug Test Kit
EZ Level Drug Screen Test Kit Dip Card
EZ Level Drug Test
EZ Level Instant Drug Test
EZ Level Instant Drug Test At Home Urine Drug Test Kit
Checkmate 12 Panel Urine Drug Test Kit
Checkmate 6 Panel Urine Drug Test Kit
Pregmate Digital Ovulation Test
PREGMATE MENOPAUSE TEST
PREGMATE Ovulation LH Test Strip
PREGMATE One Step Urine Ovulation LH Test
PREGMATE Ovulation LH Midstream Test
EZ Level Pregnancy Test Strips
Pregmate Ovulation and Pregnancy Midstream Test
Pregmate Pregnancy Midsream Test
EZ Level Ovulation and Pregnancy Test Strips
TRUE LEVEL Urinary Tract Infection UTI Test Strips
PREGMATE Urinary Tract Infection UTI Test Strips
PREGMATE Urinary Bilirubin Test Strips
True Level Urinary Bilirubin Test Strips
Pregmate Pregnancy Midstream Test
EZ Level Pregnancy Test
Establishment Types
Repack or Relabel Medical Device