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	702036	FDA UDI	Class I	Active
Salivabuse	18200180	FDA UDI	Class I	Active
Detectabuse	19481310	FDA UDI	Class I	Active
Steroid-Skreen	35062131	FDA UDI	Class I	Unknown
Detectabuse	18008248	FDA UDI	Class I	Active
Vma-Skreen	35071008	FDA UDI	Class I	Unknown
Salivabuse	18100003	FDA UDI	Class I	Unknown
Vma-Skreen	35070001	FDA UDI	Class I	Unknown
Pregnancy-Skreen	Custom QC22	FDA UDI	Class I	Unknown
Detectabuse	18008608	FDA UDI	Class I	Active
Multi-Prep	17014011	FDA UDI	Class I	Unknown
Detectabuse	Custom QC04	FDA UDI	Class I	Unknown
Detectabuse	18008336	FDA UDI	Class I	Active
Detectabuse	18008469	FDA UDI	Class I	Active
Alere	88000	FDA UDI	Class I	Active
Detectabuse	18008527	FDA UDI	Class I	Active
Steroid-Skreen	35060146	FDA UDI	Class I	Unknown
Detectabuse	88002	FDA UDI	Class I	Unknown
Detectabuse	Custom QC33	FDA UDI	Class I	Unknown
Pregnancy-Skreen	18000656	FDA UDI	Class I	Active
Detectabuse	Custom QC01	FDA UDI	Class I	Unknown
Alco-Screen	55700	FDA UDI	Class I	Active
iScreen	88033	FDA UDI	Class I	Active
Dpi	18002999	FDA UDI	Class I	Active
Cliawaived	Multitox-PC-25F	FDA UDI	Class I	Active
Pregnancy-Skreen	Custom QC18	FDA UDI	Class I	Unknown
Bio-trol	BIO-P2 6x20mL	FDA UDI	Class I	Unknown
Detectabuse	Custom QC17	FDA UDI	Class I	Unknown
Detectabuse	MULTITOX-PC-25E	FDA UDI	Class I	Active
Detectabuse	18002953	FDA UDI	Class I	Active
Detectabuse	18008419	FDA UDI	Class I	Active
Pregnancy-Skreen	Custom QC24	FDA UDI	Class I	Unknown
Detectabuse	88004	FDA UDI	Class I	Unknown
Detectabuse	Custom QC10	FDA UDI	Class I	Unknown
Detectabuse	18003209	FDA UDI	Class I	Active
Detectabuse	18030363	FDA UDI	Class I	Active
Detectabuse	18008337	FDA UDI	Class I	Active
Bio-trol	BIO-N5	FDA UDI	Class I	Unknown
Multi-Prep	14300910	FDA UDI	Class I	Unknown
Steroid-Skreen	35062114	FDA UDI	Class I	Unknown
iScreen	88030	FDA UDI	Class I	Active
Alere	88010	FDA UDI	Class I	Active
Vma-Skreen	35071555	FDA UDI	Class I	Unknown
Multi-Prep	14300925	FDA UDI	Class I	Unknown
Steroid-Skreen	35062611	FDA UDI	Class I	Unknown
iScreen	88019	FDA UDI	Class I	Active
Steroid-Skreen	35062017	FDA UDI	Class I	Unknown
iScreen	88031	FDA UDI	Class I	Active
Steroid-Skreen	35061843	FDA UDI	Class I	Unknown
Steroid-Skreen	35061738	FDA UDI	Class I	Unknown

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