Question 1

What types of medical devices does Medical Distribution Group Inc manufacture?

Accepted Answer

Medical Distribution Group Inc specializes in in-vitro diagnostic (IVD) devices focused on detecting drugs of abuse and cannabinoids. Their products include rapid immunoassay test kits, single-use test cards, multi-panel screening cups, and home testing devices. These are designed for both clinical and point-of-care use, providing results for substances like opioids, cocaine, THC, and their metabolites.

Question 2

Where is Medical Distribution Group Inc based, and how does that affect its devices?

Accepted Answer

Medical Distribution Group Inc is based in the United States, where it operates under FDA regulations. Since their devices fall under the FDA’s In Vitro Diagnostic Device Listing (IVD Listing) system, they are subject to U.S. compliance requirements, including registration, listing, and traceability through the FDA’s Unique Device Identifier (UDI) database.

Question 3

Which regulatory registries list Medical Distribution Group Inc’s devices?

Accepted Answer

Medical Distribution Group Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, allowing for tracking and monitoring of their Class II and unclassified (U) IVD products.

Question 4

How are Medical Distribution Group Inc’s devices classified under FDA regulations?

Accepted Answer

Medical Distribution Group Inc’s devices are classified as either Class II or unclassified (U) under FDA regulations. Class II devices generally require special controls to ensure their safety and effectiveness, while unclassified devices may have lower regulatory requirements but still must meet FDA standards for performance and labeling.

Question 5

What kinds of substances do Medical Distribution Group Inc’s devices detect?

Accepted Answer

Medical Distribution Group Inc’s devices detect drugs of abuse and cannabinoids, including substances like opioids, cocaine, and THC, as well as their metabolites. These products are designed for rapid, point-of-care testing, enabling quick results for clinical or home use.

Device	Model / Reference	Registries	Class	Status
Identify® Diagnostics Drug Test Cards	ID-THC-DIP-AZ5	FDA UDI	Class II	Active
Identify Home Drug Testing Device Test Cups	ID-CP13	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-THC-DIP-AZ15	FDA UDI	Class II	Active
UCP Home Drug Screening Test Cups	U-CUP-3124-RCN	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP6-AZ5	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP6-AZ15	FDA UDI	Class II	Active
UCP Home Drug Screening Test Cups	UCP12-BUP-AZ5	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP12-BUP-ADULT-AZ10	FDA UDI	U	Active
Identify® Diagnostics-Home Drug Testing Device Test Cups	ID-CP10-AZ5	FDA UDI	Class II	Active
Identify ® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup	ID-CP12-EDDP	FDA UDI	Class II	Active
UCP Home Drug Screening Test Cups	U-CUP-6104-RCN	FDA UDI	Class II	Active
Identify Health Drug Screen Test Cup	ID-H6-1	FDA UDI	Class II	Active
UCP Home Drug Screening Test Cups	U-CUP-184-RCN	FDA UDI	Class II	Active
Identify Health Drug Screen Test Cup	ID-H7-1	FDA UDI	Class II	Active
Identify Diagnostics Drug Test Cups	ID-CP12-BUP	FDA UDI	Class II	Active
Identify Health Drug Testing Device Test Cups	ID-H13-1	FDA UDI	Class II	Unknown
UCP Home Drug Screening Test Cards	U-DOA-394	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cups	ID-CP6-BUP	FDA UDI	Class II	Active
Identify Diagnostics USA	ID-US6-BUP	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-CP5-DIP-AZ15	FDA UDI	Class II	Active
Identify Health	ID-H1-DIP-THC	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-CP12-DIP-AZ25	FDA UDI	U	Active
Identify®Diagnostics Drug Test Cups	ID-CP10-AZ10	FDA UDI	U	Active
Identify Health Drug Screen Test Cup	ID-H6-3-AZ25	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cards	ID-THC-DIP	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-CP10-DIP-AZ25	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-CP12-DIP-AZ5	FDA UDI	U	Active
Identify Diagnostics Drug Test Cups	ID-CP6-AZ100	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP12-BUP-AZ5	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-CP6-DIP-AZ5	FDA UDI	Class II	Active
Identify Diagnostics Drug Test Cups	ID-CP12-BUP-ADULT	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cards	ID-THC-DIP-AZ25	FDA UDI	Class II	Active
Identify Diagnostics Drug Test Cups	ID-CP10-AZ100	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP6-AZ5	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cups	ID-CP8	FDA UDI	Class II	Active
Identify Diagnostics USA	ID-US9-ADULT-2	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cards	ID-CP7-DIP-ADULT-AZ10	FDA UDI	Class II	Active
Identify Diagnostics Drug Test Cups	ID-CP13	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP12-BUP-ADULT-AZ5	FDA UDI	Class II	Active
Bicycle Health	ID-BH9-ADULT-1-AZ25	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP10-AZ5	FDA UDI	U	Active
Identify® Diagnostics-Home Drug Testing Device Test Cups	ID-CP12-BUP-AZ5	FDA UDI	Class II	Active
Identify®Diagnostics Drug Test Cups	ID-CP10-AZ5	FDA UDI	Class II	Active
Identify Home Drug Testing Device Test Cups	ID-CP10-AZ5	FDA UDI	Class II	Active
Identify® Diagnostics-Home Drug Testing Device Test Cups	ID-CP12-BUP-ADULT-AZ5	FDA UDI	Class II	Active
Identify Home Drug Testing Device Test Cups	ID-CP12	FDA UDI	Class II	Active
Identify R Diagnostics Drug Test Cups	ID-CP12-BUP	FDA UDI	U	Active
Identify Diagnostics Drug Test Cards	ID-THC	FDA UDI	Class II	Active
UCP Home TM Drug Screening Test Cards	UCP9-DIP-B-394	FDA UDI	Class II	Active
Identify® Diagnostics Drug Test Cups	ID-CP5-BUP	FDA UDI	Class II	Active

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