Question 1

What types of medical devices does Alfa Scientific Designs, Inc. manufacture?

Accepted Answer

Alfa Scientific Designs, Inc. specializes in rapid immunochemical test kits designed for clinical and point-of-care use. Their portfolio includes urine cassettes and cup tests for detecting drugs of abuse (such as methamphetamine, cocaine, cannabinoids, and opiates), faecal occult blood, and human chorionic gonadotropin (hCG) for pregnancy testing. These tests are formulated to provide immediate visual results, often used in settings like emergency rooms, clinics, or law enforcement for quick screening.

Question 2

Where is Alfa Scientific Designs, Inc. based, and where are its devices authorized?

Accepted Answer

Alfa Scientific Designs, Inc. is based in the United States. Their devices are authorized for use in the U.S., where they are listed in regulatory databases such as the FDA’s 510(k) and Unique Device Identifier (UDI) systems. These registries track submissions for devices that have undergone the necessary regulatory pathways to demonstrate safety and performance.

Question 3

How are the devices manufactured by Alfa Scientific Designs, Inc. classified under FDA regulations?

Accepted Answer

The devices produced by Alfa Scientific Designs, Inc. fall into three classification categories under FDA regulations: Class I (generally low-risk devices with minimal regulatory controls), Class II (devices requiring special controls to ensure safety and effectiveness), and unclassified (U) devices, which may require additional evaluation or have unique risk profiles. Classification depends on factors like the device’s intended use, potential risks, and the nature of the test results.

Question 4

Which regulatory registries list the devices made by Alfa Scientific Designs, Inc.?

Accepted Answer

The devices manufactured by Alfa Scientific Designs, Inc. are listed in the FDA’s 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. The 510(k) registry tracks submissions for devices that claim substantial equivalence to a legally marketed predicate device, while the UDI system ensures standardized identification of medical devices for tracking, traceability, and regulatory compliance purposes.

Question 5

What kinds of tests does Alfa Scientific Designs, Inc. offer for fertility and health screening?

Accepted Answer

Alfa Scientific Designs, Inc. offers rapid immunochemical tests for fertility screening, specifically human chorionic gonadotropin (hCG) detection, which is commonly used in pregnancy testing. They also provide faecal occult blood tests, which are designed for early detection of potential gastrointestinal issues. These tests are formulated for point-of-care use, delivering quick results to aid in clinical decision-making.

Device	Model / Reference	Registries	Class	Status
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC	03-3520	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR MTD THC	03-4431	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MOR300, THC	03-6669	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MOR2000, MTD	03-3427QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3761QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, THC	03-3371	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC	03-6577	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THC	03-3374	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, THC	03-3463	FDA UDI	Class II	Active
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)	03-4705OT	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300	03-3932	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, THC	03-3457	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR300, PCP, THC	03-3583	FDA UDI	Class II	Active
INSTANT-VIEW LH Midstream Cassette Test, 6 tests	02-2540-6	FDA UDI	Class I	Active
INSTANT-VIEW FOB Test - complete kit, 25 test	05-7601-25	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Test AMP, BAR, BZD, COC, MOR2000, MTD, OX	03-3862QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, BUP, BZD, MET300, MOR300, T	03-3691	FDA UDI	Class II	Active
INSTANT-VIEW Methadone Urine Cassette Test	03-3172	FDA UDI	Class II	Active
INSTANT-VIEW Pregnancy Combo Cassette Test	02-2489	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test	03-4437-50	FDA UDI	Class II	Active
INSTANT-VIEW FSH Midstream Cassette Test, 2t	02-2560-2	FDA UDI	Class I	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC, XTC	03-3347	FDA UDI	Class II	Active
INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Dip-Strip Test	03-3057	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THC	03-3576	FDA UDI	Class II	Active
Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD PCP PPX THC	03-4464	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BUP, MET, MOR300, MTD	03-3519	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3951	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine (300) Urine Cassette Test	03-3030	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD	03-4570	FDA UDI	Class II	Active
Instant-View HCG Midstream Cassette	02-2480	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test MET500, MOR300, THC	03-3311	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, MOR2000, THC	03-3571QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, PCP, THC	03-3679	FDA UDI	Class II	Active
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC, OPI, THC	03-6373	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3855	FDA UDI	Class II	Active
INSTANT-VIEW Barbiturate Urine Cassette Test	03-3152	FDA UDI	Class II	Active
INSTANT-VIEW LH Ovulation Predicting Cassette Test	02-2542	FDA UDI	Class I	Active
Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC	03-4438	FDA UDI	Class II	Active
INSTANT-VIEW MDMA (XTC) Urine Dip Cassette Test	03-2952QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, THC	03-3375	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MOR300, MTD, THC	03-5051	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30	03-3945	FDA UDI	Class II	Active
INSTANT-VIEW Methadone Urine Dip Cassette Test	03-3172QW	FDA UDI	Class II	Active
INSTANT-VIEW Amphetamine (300) Urine Cassette Test	03-3014	FDA UDI	Class II	Active
Multi-Drug of Abuse Urine Cup Test	03-4680	FDA UDI	Class II	Active
INSTANT-VIEW Methadone Urine Dip-Strip Test	03-3177	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MOR, MTD, THC	03-6760QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, THC, XTC	03-3438	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET1000, THC	03-3529	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3909	FDA UDI	Class II	Active

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