FDA Registration
Active
🇺🇸 United States
JANT PHARMACAL CORP.
Reg #: 2030633
·
FEI: 3000210620
·
Expires 2026
Products
64
Proprietary Names
58
Establishment Types
1
Classifications
63
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Registration Details
- Registration Name
- JANT PHARMACAL CORP.
- Registration Number
- 2030633
- FEI Number
- 3000210620
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 16530 Ventura Blvd Ste 512
- City
- ENCINO
- State
- CA
- ZIP
- 91436
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021688
Owner / Operator
- Firm Name
- JANT PHARMACAL CORP.
- Operator Number
- 9024922
- Address
- 16530 VENTURA BLVD.,, SUITE 512
- City
- Encino
- State
- CA
- Postal Code
- 91436
- Country
- US
- Correspondent
- JACK L TAWFIK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2008-06-18 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2008-06-18 |
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2011-12-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 1997-08-11 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2009-12-02 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2019-11-19 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2019-11-19 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2013-12-26 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2013-12-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2013-12-26 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2013-12-26 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2013-12-26 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-12-10 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2014-05-19 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2021-08-26 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2011-12-15 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-11-19 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2012-11-19 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2012-11-19 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2012-11-19 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2012-11-19 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2012-11-19 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2009-12-02 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | Class 1 | Clinical Toxicology | No | 2024-12-10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 1996-03-05 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2009-12-02 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2024-12-10 |
| System Accessories, Extracorporeal | KXM | Class 2 | Gastroenterology, Urology | No | 2012-11-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2011-07-26 |
| NCI | No | 2012-11-19 | |||
| U.V. Spectrometry, Tricyclic Antidepressant Drugs | LFH | Class 2 | Clinical Toxicology | No | 2011-12-15 |
| Blood, Occult, Enzymatic Method, In Urine | JIP | Class 2 | Hematology | No | 2009-12-02 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2009-12-02 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-12-10 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2024-12-10 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2013-12-26 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2013-12-26 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2010-02-01 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2017-10-30 |
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 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
Accutest VALUPAK Drug Screen Cup
Accutest Uriscreen
ACCUTEST TCA DRUG SCREEN
ACCUTEST BENZODIAZEPINE DRUG SCREEN
Accutest® VALUPAK iFOB Immunological Fecal Occult Blood Test
Accutest Fecal Occult Blood Test
ACCUTEST COCAINE DRUG SCREEN
ACCUTEST OPIATES
HEROIN
MORPHINE DRUG SCREEN
Accutest iFOBT Dual Sample Test
ACCUTEST FINGER PUL
Establishment Types
Complaint File Establishment per 21 CFR 820.198