FDA Registration
Active
🇺🇸 United States
ALFA SCIENTIFIC DESIGNS, INC.
Reg #: 2060833
·
FEI: 3001452245
·
Expires 2026
Products
39
Proprietary Names
105
Establishment Types
3
Classifications
38
Registration Details
- Registration Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Registration Number
- 2060833
- FEI Number
- 3001452245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13200 GREGG ST.
- City
- POWAY
- State
- CA
- ZIP
- 92064
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010047
Owner / Operator
- Firm Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Operator Number
- 9034872
- Address
- 13200 GREGG ST., --
- City
- Poway
- State
- CA
- Postal Code
- 92064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2007-12-05 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2007-12-05 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2007-12-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Liquid Chromatography, Morphine | DPK | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2003-08-27 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2007-12-05 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2006-06-08 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2007-12-05 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | DOE | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-11-05 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2013-11-05 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2006-06-08 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2007-12-05 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2015-03-24 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2007-12-05 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2018-12-19 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2018-12-19 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2015-03-24 |
| NCI | No | 2007-12-05 | |||
| Thin Layer Chromatography, Tricyclic Antidepressant Drugs | MLK | Class 2 | Clinical Toxicology | No | 2007-12-05 |
Proprietary Names
Instant-View Phencyclidine (PCP) Urine Cassette Test
Phencyclidine (PCP) Urine Cassette Test
hCG Pregnancy Combo Cassette Test
Instant-View Pregnancy Combo Cassette Test
Instant-View LH Ovulation Test
LH Ovulation Test
Methadone (MTD) Urine Dip Strip Test
Instant-View Methadone (MTD) Urine Dip Strip Test
Instant-View Morphine Urine Dip Strip Test
Morphine Urine Dip Strip Test
Instant-View MDMA (Ecstasy, XTC) Urine Test (Cassette/Dip Strip)
MDMA (Ecstasy, XTC) Urine Test (Cassette/Dip Strip)
FSH Menopause Test
Instant-View FSH Menopause Test
Instant-View Troponin I Rapid Test - Serum (Cassette/Dip Strip)
Instant-View Troponin I Rapid Test Whole Blood/ Serum (Cassette)
Troponin I Rapid Test Whole Blood/ Serum (Cassette)
Troponin I Rapid Test - Serum (Cassette/Dip Strip)
Instant-View Methamphetamine Urine Cassette Test
Methamphetamine Urine Cassette Test
Marijuana (THC) Urine Dip Strip Test
Instant-View Marijuana (THC) Urine Dip Strip Test
Instant-View Benzodiazepine (BZD) Urine Cassette Test
Benzodiazepine (BZD) Urine Cassette Test
H. pylori Rapid Test Whole Blood/Serum (Cassette)
Instant-View H. pylori Rapid Test Whole Blood/Serum (Cassette)
H. pylori Rapid Test - Serum (Cassette/Dip Strip)
Instant-View H. pylori Rapid Test - Serum (Cassette/Dip Strip)
Multi-Drug Screen Urine Test
Instant-View Multi-Drug Screen Urine Test
Multi-Drugs of Abuse Urine Cup Test
Multi-Drugs of Abuse Urine Panel Test
Instant-View Multi-Drugs of Abuse Urine Panel Test
Instant-View Multi-Drugs of Abuse Urine Cup Test
Instant-View Strep A test
Instant-View Pregnancy Urine Dip Strip Test
hCG Pregnancy Urine Dip Strip Test
Instant-View LH Ovulation Predicting Midstream Test
LH Ovulation Predicting Midstream Test
Saliva Alcohol Strip
Instant-View Fecal Occult Blood (FOB) Self-Test
Fecal Occult Blood (FOB) Self-Test
Instant-View plus FOB Test
Fecal Occult Blood (FOB) Test (Cassette/Dip Strip)
Instant-View Fecal Occult Blood (FOB) Test (Cassette/Dip Strip)
Propoxyphene (PPX) Urine Test (Cassette/Dip Strip)
Instant-View Propoxyphene (PPX) Urine Test (Cassette/Dip Strip)
hCG Pregnancy Combo Dip Strip Test
Instant-View Pregnancy Combo Dip Strip Test
Instant-View Morphine (2000) Urine Cassette Test
Morphine (2000) Urine Cassette Test
Instant-View Amphetamine Urine Cassette Test
Amphetamine (AMP) Urine Cassette Test
Instant-View Morphine Urine Cassette Test
Morphine Urine Cassette Test
Instant-View Barbiturate Urine Dip Strip Test
Barbiturate (BAR) Urine Dip Strip Test
Marijuana (THC) Urine Test (Cassette)
Instant-View Marijuana (THC) Urine Test (Cassette)
Instant-View Morphine (2000) Urine Dip Strip Test
Morphine (2000) Urine Dip Strip Test
Instant-View Plus Multi-Drugs of Abuse Urine Simple Cup Test
Simple Cup, (THC) Drug Screen Test
Simple Cup, Multi-12 (AM BA BZ CO ME MO MT OX300 PC TC TH MD) W/ADU (CR pH SG NI OX) Drug Screen Test
Simple Cup, Multi-5 (AM CO ME MO TH) Drug Screen Test
Detactabuse Liquid Control
Methamphetamine (1000) Urine Dip Strip Test
Instant-View Methamphetamine (1000) Urine Dip Strip Test
Instant-View Methadone (MTD) Urine Cassette Test
Methadone (MTD) Urine Cassette Test
Instant-View Methamphetamine (1000) Urine Cassette Test
Methamphetamine (1000) Urine Cassette Test
Phencyclidine (PCP) Urine Dip Strip Test
Instant-View Phencyclidine (PCP) Urine Dip Strip Test
Instant-View Barbiturate Urine Cassette Test
Barbiturate (BAR) Urine Cassette Test
Instant-View Methamphetamine (300) Urine Test (Cassette/Dip Strip)
Instant-View Oxycodone (100) Urine Test (Cassette/Dip Strip)
Cocaine (150) Urine Test (Cassette/Dip Strip)
Instant-View Amphetamine (300) Urine Test (Cassette/Dip Strip)
Instant-View Oxycodone (300) Urine Test (Cassette/Dip Strip)
Instant-View Cocaine (150) Urine Test (Cassette/Dip Strip)
Methamphetamine (300) Urine Test (Cassette/Dip Strip)
Oxycodone (100) Urine Test (Cassette/Dip Strip)
Oxycodone (300) Urine Test (Cassette/Dip Strip)
Amphetamine (300) Urine Test (Cassette/Dip Strip)
TCA Urine Test (Cassette/Dip Strip)
Instant-View TCA Urine Test (Cassette/Dip Strip)
Instant-View Pregnancy Mid-Stream Test
hCG Pregnancy Mid-Stream Test
Instant-View Amphetamine Urine Dip Strip Test
Amphetamine (AMP) Urine Dip Strip Test
Clinitest hCG Pregnancy Test
Benzodiazepine (BZD) Urine Dip Strip Test
Instant-View Benzodiazepine (BZD) Urine Dip Strip Test
Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test
Cocaine Urine Dip Strip Test
Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test
Cocaine Urine Cassette Test
Instant-View Buprenorphine (BUP) Urine Test (Cassette/Dip Strip)
Buprenorphine (BUP) Urine Test (Cassette/Dip Strip)
Instant-View Pregnancy Urine Cassette Test
hCG Pregnancy Urine Cassette Test
Instant-View Methamphetamine Urine Dip Strip Test
Methamphetamine Urine Dip Strip Test
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)