ALFA SCIENTIFIC DESIGNS, INC.

FDA Device Registration & Listing · POWAY, CA, US · Registration 2060833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2060833
FEI Number
3001452245
Entity Name
ALFA SCIENTIFIC DESIGNS, INC.
City/State/Country
POWAY, CA, US
Establishment Address
13200 GREGG ST., POWAY, CA 92064, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ALFA SCIENTIFIC DESIGNS, INC. (Owner Number: 9034872)
Owner / Operator Contact Address
13200 GREGG ST., --, Poway, CA 92064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K010015
PMA Number
N/A

All Registered 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 Multi-Drugs of Abuse Urine Cup Test 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2007-12-05
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2007-12-05
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2007-12-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2007-12-05
DPK Liquid Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2007-12-05
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2003-08-27
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2007-12-05
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2006-06-08
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2007-12-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2007-12-05
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2007-12-05
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2007-12-05
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2007-12-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2007-12-05
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2007-12-05
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2007-12-05
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2007-12-05
DPK Liquid Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2007-12-05
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2007-12-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2007-12-05
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2007-12-05
DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Clinical Toxicology Class 2 862.3640 2007-12-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2007-12-05
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2013-11-05
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2013-11-05
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2013-11-05
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2013-11-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2013-11-05
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2013-11-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2013-11-05
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2013-11-05
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2013-11-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2013-11-05
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2006-06-08
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2007-12-05
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 1999-09-09
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Clinical Toxicology Class 2 862.3040 2015-03-24
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2018-10-30
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-10-30
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-10-30
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-10-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-10-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-10-30
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2018-10-30
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-10-30
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2018-10-30
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-10-30
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2007-12-05
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2023-06-08
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2007-12-05
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2007-12-05
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2007-12-05
DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Clinical Toxicology Class 2 862.3640 2007-12-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2007-12-05
DPK Liquid Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2007-12-05
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2007-12-05
DKE Reagents, Test, Tetrahydrocannabinol Clinical Toxicology Class 2 862.3870 2007-12-05
DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Clinical Toxicology Class 2 862.3640 2007-12-05
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2018-12-19
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2018-12-19
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2018-12-19
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-12-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-12-19
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-12-19
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2018-12-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-12-19
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-12-19
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-12-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-12-19
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-12-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-12-19
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2018-12-19
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2018-12-19
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2018-12-19
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-12-19
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-12-19
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-12-19
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-12-19
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-12-19
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2015-03-24
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2007-12-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2007-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALFA SCIENTIFIC DESIGNS, INC.
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
K924751 Solarcare Technologies Corp,Inc. SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY 1992-12-11
K142044 Guangzhou Wondfo Biotech Co., Ltd. CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE 2014-08-25
K163220 Siemens Healthcare Diagnostics, Inc. Atellica CH Phencyclidine (Pcp) 2017-04-06
K964536 Teco Diagnostics ONE-STEP DIPSTICK PREGNANCY TEST 1997-02-11
K904016 Bhc Biotech , Ltd. MAXI TEST 1990-10-15

Related Recall Records

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Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0032-2022 Beckman Coulter Inc. 2
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021 Siemens Healthcare Diagnostics, Inc. 2
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2060833. Last updated year: 2026. Please use registration number 2060833 when referencing this establishment in official correspondence.
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