FDA Registration Active 🇺🇸 United States

Instant-View Multi-Drugs of Abuse Urine Panel Test

Reg #: 2060833 · FEI: 3001452245 · Expires 2025
Products
10
Proprietary Names
4
Establishment Types
3
Classifications
10

Registration Details

Registration Name
ALFA SCIENTIFIC DESIGNS, INC.
Registration Number
2060833
FEI Number
3001452245
Status
Active
Expiry Year
2025
Initial Importer
No
Address
13200 GREGG ST.
City
POWAY
State
CA
ZIP
92064
Country
US

Regulatory Submissions

510(k) Number
K131645

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
Enzyme Immunoassay, Opiates DJG
Thin Layer Chromatography, Methamphetamine DJC
Enzyme Immunoassay, Barbiturate DIS
Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
Enzyme Immunoassay, Methadone DJR
Enzyme Immunoassay, Benzodiazepine JXM
Enzyme Immunoassay, Phencyclidine LCM
Enzyme Immunoassay, Cannabinoids LDJ
Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
Enzyme Immunoassay, Amphetamine DKZ

Proprietary Names

Instant-View Multi-Drugs of Abuse Urine Panel Test Multi-Drugs of Abuse Urine Panel Test Instant-View Multi-Drugs of Abuse Urine Cup Test Multi-Drugs of Abuse Urine Cup Test

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device