Question 1

What types of medical devices does Biochemical Diagnostics Inc manufacture?

Accepted Answer

Biochemical Diagnostics Inc specializes in in vitro diagnostic (IVD) products, primarily controls and reagents for detecting drugs of abuse in urine samples. Their portfolio includes multi-panel tests for various substances, ethanol (ETOH) controls, and kits for measuring 17-hydroxycorticoid levels using spectrophotometry. They also produce controls for urine analyte testing, a human chorionic gonadotropin beta-core fragment test, pregnancy screening devices, and a vital sign monitoring device. These products are designed for laboratory and point-of-care use.

Question 2

Where is Biochemical Diagnostics Inc based, and what does that mean for regulatory oversight?

Accepted Answer

Biochemical Diagnostics Inc is based in the United States. Since the company operates in the U.S., its devices are subject to FDA regulations, including premarket notification (510(k)) requirements for Class I devices and compliance with the FDA’s Unique Device Identifier (UDI) system. The company’s products are also listed in the EU’s EUDAMED database, indicating they may be marketed or used in the European Union under applicable IVD regulations, though this does not imply EU approval.

Question 3

How are the devices manufactured by Biochemical Diagnostics Inc classified under regulatory frameworks?

Accepted Answer

The devices produced by Biochemical Diagnostics Inc fall under Class I classification and In Vitro Diagnostic (IVD) General categories. Class I devices are typically considered low-risk, often requiring general controls like labeling and manufacturing practices, while IVD General classifications apply to diagnostic tests that do not pose significant health risks. This classification helps determine the regulatory pathway, such as FDA’s 510(k) process for Class I devices, ensuring compliance without stringent pre-market approval.

Question 4

Which regulatory registries list the devices made by Biochemical Diagnostics Inc?

Accepted Answer

The devices manufactured by Biochemical Diagnostics Inc are listed in three key regulatory registries: EUDAMED, the European database for medical devices; the FDA’s 510(k) premarket notification database, which tracks Class I device submissions in the U.S.; and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking. These listings reflect the company’s adherence to regulatory requirements in both the U.S. and EU markets, though they do not confirm individual device approvals.

Question 5

Why do some of the company’s devices appear under multiple names (e.g., Detectabuse vs. DETECTABUSE)?

Accepted Answer

The variations in naming conventions (e.g., *Detectabuse* vs. *DETECTABUSE*) likely reflect differences in branding, case sensitivity in labeling, or regional marketing preferences. Some devices may also appear under multiple names due to updates, rebranding, or variations in product lines (e.g., controls vs. kits). These discrepancies do not affect regulatory classification or compliance but may appear in databases or documentation depending on how the manufacturer registers or lists the device. Always refer to the official labeling or regulatory submissions for precise identification.

Device	Model / Reference	Registries	Class	Status
Detectabuse	18003208	FDA UDI	Class I	Active
Detectabuse	702037	FDA UDI	Class I	Active
Steroid-Skreen	35062106	FDA UDI	Class I	Unknown
Detectabuse	Custom QC14	FDA UDI	Class I	Unknown
Detectabuse	18003078	FDA UDI	Class I	Active
Detectabuse	18008335	FDA UDI	Class I	Active
Detectabuse	18002836	FDA UDI	Class I	Active
Detectabuse	18008256	FDA UDI	Class I	Active
Detectabuse	18030393	FDA UDI	Class I	Active
Dpi	18002998	FDA UDI	Class I	Active
Detectabuse	18001422	FDA UDI	Class I	Active
Vma-Skreen	35071903	FDA UDI	Class I	Unknown
Alere	88002	FDA UDI	Class I	Active
Detectabuse	MULTITOX-NC-25	FDA UDI	Class I	Active
Salivabuse	18200177	FDA UDI	Class I	Active
Detectabuse	18030392	FDA UDI	Class I	Active
Steroid-Skreen	35062211	FDA UDI	Class I	Unknown
Detectabuse	18002145	FDA UDI	Class I	Active
Detectabuse	18008511	FDA UDI	Class I	Active
Detectabuse	18008472	FDA UDI	Class I	Active
iScreen	88006	FDA UDI	Class I	Active
Steroid-Skreen	35062408	FDA UDI	Class I	Unknown
Detectabuse	Custom QC05	FDA UDI	Class I	Unknown
Detectabuse	18008466	FDA UDI	Class I	Active
Detectabuse	18008333	FDA UDI	Class I	Active
Pregnancy-Skreen	Custom QC30	FDA UDI	Class I	Unknown
Alere	88001	FDA UDI	Class I	Active
Premier	PQ-22-01	FDA UDI	Class I	Active
Detectabuse	18008622	FDA UDI	Class I	Active
Detectabuse	19481320	FDA UDI	Class I	Active
Detectabuse	18002929	FDA UDI	Class I	Active
Detectabuse	18008051	FDA UDI	Class I	Active
Vma-Skreen	35071202	FDA UDI	Class I	Unknown
Adulter-Skreen	20300002	FDA UDI	Class I	Active
Vma-Skreen	35071601	FDA UDI	Class I	Unknown
Detectabuse	18007568	FDA UDI	Class I	Active
Steroid-Skreen	35066242	FDA UDI	Class I	Unknown
Detectabuse	18030394	FDA UDI	Class I	Active
Vma-Skreen	35071504	FDA UDI	Class I	Unknown
Steroid-Skreen	35061924	FDA UDI	Class I	Active
Steroid-Skreen	35062807	FDA UDI	Class I	Active
Detectabuse	18030390	FDA UDI	Class I	Active
Detectabuse	18008249	FDA UDI	Class I	Active
Detectabuse	18003226	FDA UDI	Class I	Active
Detectabuse	18003079	FDA UDI	Class I	Active
Vma-Skreen	35071156	FDA UDI	Class I	Unknown
Detectabuse	Custom QC20	FDA UDI	Class I	Active
Detectabuse	14100325	FDA UDI	Class I	Unknown
Salivabuse	18100185	FDA UDI	Class I	Active
Detectabuse	18003009	FDA UDI	Class I	Active

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