Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030633

FEI Number

3000210620

Entity Name

JANT PHARMACAL CORP.

City/State/Country

ENCINO, CA, US

Establishment Address

16530 Ventura Blvd Ste 512, ENCINO, CA 91436, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

JANT PHARMACAL CORP. (Owner Number: 9024922)

Owner / Operator Contact Address

16530 VENTURA BLVD.,, SUITE 512, Encino, CA 91436, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012595

PMA Number

N/A

All Registered Proprietary Names

NICALERT Accutest Breath Alcohol Detector ACCUTEST AMPHETAMINE DRUG SCREEN Accutest Buprenorphine Drug Screen Accutest M2 Microalbumin Urine Reagent Strips Accustrip Value+ hCG Urine Preg Test Strip Accutest 500 Urinalysis Analyzer Accutest Multi Drug Test Cup Accustrip Strep A Value+ Group A Streptococcus Antigen Test Accutest Multi-Drug Screen Accustrip Value+Strep A Test Strip Accutest Value+ MultiDrug Urine Test Cup ACCUTEST BARBITURATE DRUG SCREEN AccuGen Clinical Sample Concentrator Accutest MultiDrug Test Cup Accustrip Saliva Alcohol Test Strip LipidPlus Cholesterol & Glucose Measuring System Accutest URS-10 Urine Reagent Strip Accutest Saliva Cotinine Drug Test ACCUTEST MIDSTREAM PREGNANCY TEST Accutest® VALUPAK hCG Urine Pregnancy Test Cassette ACCUTEST METHAMPHE Accutest MDMA (Ecstasy) Test Accutest TSH Test Accustrip VALUPAK Strep A Test Strip ACCUTEST PCP DRUG SCREEN Accutest Accutest URS Series Reagent Strips for Urinalysis ACCUTEST MORPHINE DRUG SCREEN Accutest Drug Test Cup Accutest Oxycodone Drug Screen LipidPlus Professional Lipid Profile and Glucose Measuring System Accutest MultiDrug Test Card ACCUTEST THC DRUG SCREEN Accutest SleepPro 3000 Accutest Clear MultiDrug Test Accutest X Drug Test Cup Accutest ER11 MultiDrug Test Device Accutest URS Series Reagent Strips for Urinalysis Accutest Drug Test Cup Accutest Propoxyphene Drug Screen Accutest Value+ hCG Urine Preg Cassette Accustrip URS Urine Reagent Strips Accutest Value+ Urine/Serum hCG Preg Test Accutest H. Pylori Urease Rapid Test Accutest Rapid Mono Test Cassette Accutest H. Pylori Rapid Test Device ACCUTEST METHADONE DRUG SCREEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-06-18
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2008-06-18
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2011-12-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	1997-08-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-12-02
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2019-11-19
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2019-11-19
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-12-26
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2013-12-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2013-12-26
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2013-12-26
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-12-26
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2013-12-26
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2013-12-26
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2013-12-26
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2013-12-26
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2013-12-26
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2013-12-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-12-10
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-12-10
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-12-10
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-12-10
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-12-10
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-12-10
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-12-10
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-12-10
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-12-10
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-12-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-12-10
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2014-05-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-12-10
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-12-10
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-12-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-12-10
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-12-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-12-10
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2024-12-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-12-10
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-12-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-12-10
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2011-08-08
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-11-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-11-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-11-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2019-11-19
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2019-11-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2019-11-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-11-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-11-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-11-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2019-11-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2019-11-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2001-10-02
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-08-26
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-11-09
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2011-12-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-11-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-11-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-11-19
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2012-11-19
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2012-11-19
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2012-11-19
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-12-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-12-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-12-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-12-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-12-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-12-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-12-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-12-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-12-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-12-02
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-12-10
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2024-12-10
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	1996-03-05
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2017-10-30
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	1997-08-11
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-12-02
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2009-12-02
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2018-12-26
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	1997-08-11
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2009-05-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-05-07
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-05-07
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-05-07
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-05-07
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-05-07
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2024-12-10
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2024-12-10
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-12-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-12-10
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2024-12-10
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-12-10
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2024-12-10
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-12-10
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2024-12-10
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2024-12-10
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2024-12-10
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-12-10
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2006-03-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2006-03-14
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2011-12-15
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2011-12-15
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2011-12-15
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2011-12-15
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2011-12-15
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2011-12-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2011-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2011-12-15
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2011-12-15
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2011-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-12-02
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2014-04-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-04-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-21
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2014-04-21
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-04-21
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2014-04-21
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-11-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-11-19
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2012-11-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-11-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2012-11-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-11-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-11-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-11-19
KXM	System Accessories, Extracorporeal	Gastroenterology, Urology	Class 2	876.5820	2012-11-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-11-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	1997-08-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-07-26
NCI	N/A	N/A	Class N/A	N/A	2012-11-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-11-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-11-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-11-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-11-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-11-19
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2012-11-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2012-11-19
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2012-11-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-11-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-11-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-11-19
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2011-12-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2011-12-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2011-12-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2011-12-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2011-12-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2011-12-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2011-12-15
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2011-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2011-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2011-12-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-11-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-11-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-11-19
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-11-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2012-11-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-11-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-11-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2012-11-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-11-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-11-19
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-12-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-12-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2009-12-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-12-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-12-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-12-02
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2009-12-02
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2009-12-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-12-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-12-02
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Hematology	Class 1	864.9320	2009-12-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-12-02
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-12-10
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-12-10
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-12-10
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-12-10
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2024-12-10
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-12-10
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-12-10
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-12-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-12-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-12-10
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-12-10
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-12-10
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-12-10
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-12-10
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-12-10
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-12-10
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2024-12-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-12-10
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-12-10
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-12-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-12-10
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2024-12-10
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-02-04
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-12-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-12-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-12-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-12-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-12-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-12-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-12-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-12-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-12-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-12-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-12-02
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-12-26
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2013-12-26
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2013-12-26
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2011-12-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	1997-08-11

Official Correspondent

JACK TAWFIK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JANT PHARMACAL CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K803039	General Diagnostics	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	1980-12-22
K970265	Drial Consultants, Inc.	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	1997-04-08
K051161	Quest Diagnostics, Inc.	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	2005-11-22
K122904	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	2012-11-15
K121987	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST	2012-08-01

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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1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
2022375	UTAK LABORATORIES, INC.	VALENCIA, CA, US
2016706	Bio-Rad Laboratories Inc.	IRVINE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030633. Last updated year: 2026. Please use registration number 2030633 when referencing this establishment in official correspondence.