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 Benzodiazepine (BZD) Urine Cassette Test	03-3132	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BUP, BZD, COC, MET MOR/OPI3	03-6933	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, MOR2000, THC	03-3459QW	FDA UDI	Class II	Active
INSTANT-VIEW FOB Test	05-7602-50	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, COC, MET1000, THC	03-3522	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3761	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, MET500, MOR300 PCP,	03-3701	FDA UDI	Class II	Active
INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test	03-3072OT-5	FDA UDI	Class II	Active
Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC	03-4429	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR2000, THC	03-3533	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR, THC	03-3373	FDA UDI	Class II	Active
Cocaine (Benzoylecgonine) Urine Cassette Test	03-3062	FDA UDI	Class II	Active
INSTANT-VIEW FSH Dip-Strip Test	02-2567	FDA UDI	Class I	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, THC, XTC	03-3420	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR300, THC	03-3377-10	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3910QW	FDA UDI	Class II	Active
INSTANT-VIEW Phencyclidine (PCP) Urine Dip-Strip Test	03-3117	FDA UDI	U	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300	03-3924	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, TCA	03-3349-10	FDA UDI	Class II	Active
INSTANT-VIEW FOB Test	05-7602	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test (AMP, BZD, COC, MET, MOR300, THC)	03-3654	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR PCP THC	03-4430	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR MTD OXY	03-4579	FDA UDI	Class II	Active
INSTANT-VIEW Pregnancy Urine Dip-Strip Test	02-2487-25	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR/OPI300, THC, XT	03-3627	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC	03-3551	FDA UDI	Class II	Active
INSTANT-VIEW OXY100 Urine Dip Cassette Test	03-2862QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MET, MOR300 PCP,	03-6995	FDA UDI	Class II	Active
INSTANT-VIEW FOB Test - complete kit, 50 test	05-7601-50	FDA UDI	Class II	Active
Instant-View HCG Midstream Cassette, 2t	02-2480-2	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, COC, MET, MOR300, THC, XT	03-3766	FDA UDI	Class II	Active
INSTANT-VIEW MDMA (XTC) Urine Dip-Strip Test	03-2957	FDA UDI	Class II	Active
INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Dip Cassette Test	03-3052QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200	03-3910	FDA UDI	Class II	Active
INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Dip-Strip Test	03-2847	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR300, THC	03-3425	FDA UDI	Class II	Active
INSTANT-VIEW Amphetamine Urine Cassette Test	03-3012	FDA UDI	Class II	Active
INSTANT-VIEW Pregnancy Urine Dip-Strip Test	02-2487	FDA UDI	Class II	Active
INSTANT-VIEW Barbiturate Urine Dip-Strip Test	03-3157	FDA UDI	Class II	Active
INSTANT-VIEW Morphine/Opiates (300) Urine Dip-Strip Test	03-3098	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, MOR2000, THC	03-3571	FDA UDI	Class II	Active
INSTANT-VIEW TCA Urine Dip-Strip Test	03-2977	FDA UDI	Class II	Active
INSTANT-VIEW Morphine (2000) Urine Dip Cassette Test	03-3092QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BZD, COC, MOR300, THC, XTC	03-6685	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, THC	03-3338	FDA UDI	Class II	Active
Instant-View Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC, XTC	03-6650	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, COC, MET1000, THC	03-3537	FDA UDI	Class II	Active
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC, THC	03-6270	FDA UDI	Class II	Active
INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	03-4701	FDA UDI	Class II	Active
Instant-view plus Immunochemical Fecal Occult Blood Test	05-7632OT	FDA UDI	Class II	Active

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