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 Pregnancy Combo Dip-Strip Test	02-2488	FDA UDI	Class II	Active
INSTANT-VIEW Benzodiazepine (BZD) Urine Dip Cassette Test	03-3132QW	FDA UDI	Class II	Active
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)	03-4703OT	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR20	03-3997	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300	03-3860QW	FDA UDI	Class II	Active
Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI OXY PCP THC	03-4433	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test	03-3764	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MOR/OPI300, MTD,	03-6763	FDA UDI	Class II	Active
INSTANT-VIEW H. pylori Rapid Test	05-9475	FDA UDI	Class I	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3963	FDA UDI	Class II	Active
INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test	03-3072OT-10	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR20	03-3762	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine (500) Urine Dip-Strip Test	03-3038	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC	03-3270-20	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, BZD, COC, MOR300, MTD, THC	03-3689	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, COC, MET1000, MOR2000, TH	03-3678	FDA UDI	Class II	Active
INSTANT-VIEW Amphetamine (300) Urine Dip-Strip Test	03-3019	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine Urine Dip-Strip Test	03-3037	FDA UDI	Class II	Active
INSTANT-VIEW Troponin I Serum Cassette Test	05-8572	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR20	03-3997QW	FDA UDI	Class II	Active
INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Cassette Test	03-3052	FDA UDI	Class II	Active
INSTANT-VIEW OXY300 Urine Dip Cassette Test	03-2863QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, COC, THC	03-6375QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET500, MOR300, THC	03-3445	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THC	03-3577OT-5	FDA UDI	Class II	Active
INSTANT-VIEW H. Pylori Serum Cassette Test	05-9473	FDA UDI	Class I	Active
INSTANT-VIEW FSH Cassette Test	02-2562	FDA UDI	Class I	Active
INSTANT-VIEW FOB Test	05-7602-2	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine (1000) Urine Dip Cassette Test	03-3032QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET500, MOR300, THC, XTC	03-3642-10	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3916	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET1000, THC	03-3461	FDA UDI	Class II	Active
INSTANT-VIEW Morphine/Opiates (2000) Urine Cassette Test	03-3092	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test MET, THC	03-3226	FDA UDI	Class II	Active
INSTANT-VIEW Phencyclidine (PCP) Urine Dip Cassette Test	03-3112QW	FDA UDI	U	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR THC	03-4424	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test BZD, MOR300, OXY	03-6309QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP300, BAR, BZD, COC, MET, MOR300 MT	03-6915	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR300, PCP, THC	03-3562	FDA UDI	U	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300	03-3965QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR, THC, XTC	03-3639	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET1000, MOR300, PCP, TH	03-3631	FDA UDI	Class II	Active
Pregnancy Combo Cassette Test	02-2493	FDA UDI	Class II	Active
INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test	03-2932	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THC	03-3577	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR/OPI300, THC	03-3377	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP300, COC, MET300, MOR300, THC30, X	03-6665	FDA UDI	Class II	Active
INSTANT-VIEW FOB Test	05-7602	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MET, MOR PCP, TCA	03-6996	FDA UDI	Class II	Active
INSTANT-VIEW H. Pylori Serum Cassette Test	05-9472	FDA UDI	Class I	Active

Alfa Scientific Designs, Inc.

About

What Alfa Scientific Designs, Inc. makes

Frequently asked questions

Information

Catalogue (268)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities