Data / Medical devices / United States / Alfa Scientific Designs, Inc.
Alfa Scientific Designs, Inc.: FDA-registered device maker in Poway, CA, United States, 45 510(k) clearances
Alfa Scientific Designs, Inc. is registered with the FDA (registration 2060833) in Poway, CA, United States. It lists 39 device types. The FDA files 45 510(k) clearances under its listings, the newest dated February 23, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2060833
- FEI number
- 3001452245
- Address
- 13200 Gregg ST., Poway, CA, United States, 92064
- Owner or operator
- ALFA SCIENTIFIC DESIGNS, INC. (9034872)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- September 9, 1999
- Registered through
- 2026
- Brand names listed
- Amphetamine (300) Urine Test (Cassette/Dip Strip), Amphetamine (AMP) Urine Cassette Test, Amphetamine (AMP) Urine Dip Strip Test, Barbiturate (BAR) Urine Cassette Test, Barbiturate (BAR) Urine Dip Strip Test, Benzodiazepine (BZD) Urine Cassette Test, Benzodiazepine (BZD) Urine Dip Strip Test, Buprenorphine (BUP) Urine Test (Cassette/Dip Strip) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drug Mixture Control Materials | DIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Barbiturate | DIS | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Benzodiazepine | JXM | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Methadone | DJR | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Propoxyphene | JXN | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Liquid Chromatography, Morphine | DPK | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| NCI | NCI | Manufacturer | accessdata.fda.gov | |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | DOE | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagents, Test, Tetrahydrocannabinol | DKE | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Test, Amphetamine, Over The Counter | NFT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Barbiturate, Over The Counter | PTH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Benzodiazepine, Over The Counter | NFV | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Cannabinoid, Over The Counter | NFW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Test, Methadone, Over The Counter | PTG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Methamphetamine, Over The Counter | NGG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Morphine, Over The Counter | NGI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Opiates, Over The Counter | NGL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Methamphetamine | DJC | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Thin Layer Chromatography, Morphine | DNK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Tricyclic Antidepressant Drugs | MLK | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2018 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 15, 2018 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| June 24, 2016 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| October 7, 2013 | K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 3, 2012 | K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | DIF | Substantially Equivalent | Biochemical Diagnostic, Inc. | accessdata.fda.gov |
| October 4, 2011 | K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | DIC | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| June 21, 2007 | K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 7, 2007 | K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | DJG | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 25, 2006 | K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | DJG | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| November 19, 2004 | K042227 | INSTANT-VIEW TROPONIN I TEST | MMI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| December 23, 2003 | K032563 | CLINITEST HCG PREGNANCY TEST | JHI | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| June 10, 2003 | K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | LYR | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| December 9, 2002 | K022693 | INSTANT-VIEW TCA URINE TEST | MLK | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| November 29, 2002 | K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | JXN | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| November 13, 2002 | K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | DJC | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| November 5, 2002 | K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | CEP | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 30, 2002 | K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| June 17, 2002 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | DIS | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | DOE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | DOE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | LCM | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST | LCM | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST | DJR | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST | DJR | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003881 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST | JXM | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003879 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) | JXM | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003847 | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) | LAF | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) | LAF | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST | DIS | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 14, 2000 | K994406 | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | DJC | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 14, 2000 | K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST | DIO | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 7, 2000 | K994395 | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 4, 2000 | K994400 | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST | DJC | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 4, 2000 | K994399 | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST | DKZ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 27, 2000 | K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST | DIO | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 10, 2000 | K994409 | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST | DPK | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 5, 2000 | K994404 | INSTANT-VIEW MORPHINE URINE CASSETTE TEST | DPK | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| June 21, 2000 | K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST | LDJ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| June 2, 2000 | K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | DKE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984080 | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST | JHI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | JHI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984077 | INSTANT-VIEW PREGNANCY COMBO TEST | JHI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984076 | INSTANT-VIEW PREGNANCY URINE TEST | JHI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | LCX | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Thin Layer Chromatography, Methamphetamine
- All makers of Gas Chromatography, Methamphetamine
- All makers of Enzyme Immunoassay, Phencyclidine
- All makers of Thin Layer Chromatography, Morphine
- All makers of Test, Opiates, Over The Counter
- All makers of Enzyme Immunoassay, Cannabinoids
Updated February 23, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.