Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013679502

FEI Number

3013679502

Entity Name

PREGMATE LLC

City/State/Country

Hollywood, FL, US

Establishment Address

3804 N 29th Ave, Hollywood, FL 33020, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PREGMATE LLC (Owner Number: 10055200)

Owner / Operator Contact Address

2268 ANCHOR CT, Fort Lauderdale, FL 33312, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012252

PMA Number

N/A

All Registered 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 Multi-Drug Testing Kit TRUE LEVEL Instant Drug Test TRUE LEVEL Drug Test TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit 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 PREGMATE Ketone Test Strips TRUE LEVEL Ketone Test Strips TRUE LEVEL Drug Screen Test Kit Dip Card TRUE LEVEL Multi-Drug Testing Kit TRUE LEVEL Instant Drug Test TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit TRUE LEVEL Drug Test 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 True Level Urinary Tract Infection UTI Test Pregmate Urinary Tract Infection UTI Test TRUE LEVEL Instant Drug Test TRUE LEVEL Drug Test TRUE LEVEL Multi-Drug Testing Kit TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit Pregmate Pregnancy Test Pregmate Ovulation and Pregnancy Test Strips Pregmate Pregnancy Test Strips Pregmate Pregnancy Test Pregmate Pregnancy Test Strips Pregmate Ovulation Test EZ Level Ovulation Test Pregmate Digital Ovulation Test EZ Level Ovulation Test Strips Pregmate Ovulation Midstream Test Pregmate Ovulation Test Strips PREGMATE MENOPAUSE TEST PREGMATE Ovulation LH Test PREGMATE Ovulation LH Test Strip PREGMATE One Step Urine Ovulation LH Test PREGMATE Ovulation LH Midstream Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2018-01-30
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2018-01-30
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2023-02-03
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-02-03
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2017-07-14
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-07-14
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2018-01-30
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-07-14
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-07-14
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-07-14
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2018-01-30
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2018-01-30
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2017-06-19
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2017-06-19
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2018-01-30
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2017-06-19
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2017-06-19
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2018-01-30
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-01-30
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-06-19
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2017-06-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-06-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-06-19
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-06-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-06-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-06-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-06-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-06-19
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2017-06-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-06-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-06-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-06-19
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2018-01-30
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-07-14
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-07-14
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2023-02-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-02-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-02-03
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2018-01-30
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-01-21
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2017-06-19

Official Correspondent

VIKTAR MAROZAU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PREGMATE 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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013679502. Last updated year: 2026. Please use registration number 3013679502 when referencing this establishment in official correspondence.