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	Custom QC09	FDA UDI	Class I	Unknown
Detectabuse	18002142	FDA UDI	Class I	Active
Detectabuse	18004096	FDA UDI	Class I	Active
Detectabuse	18003101	FDA UDI	Class I	Active
Detectabuse	18003216	FDA UDI	Class I	Active
Detectabuse	88010	FDA UDI	Class I	Unknown
Detectabuse	18003006	FDA UDI	Class I	Unknown
Detectabuse	Custom QC32	FDA UDI	Class I	Unknown
Detectabuse	18008288	FDA UDI	Class I	Active
Bio-trol	BIO-N 6x20mL	FDA UDI	Class I	Unknown
Pregnancy-Skreen	Custom QC25	FDA UDI	Class I	Unknown
Detectabuse	18008423	FDA UDI	Class I	Active
Detectabuse	18008422	FDA UDI	Class I	Active
Vma-Skreen	35071105	FDA UDI	Class I	Unknown
Detectabuse	14100820	FDA UDI	Class I	Unknown
Clarity Diagnostics	CD-DOACTLS10	FDA UDI	Class I	Active
Vma-Skreen	35071709	FDA UDI	Class I	Unknown
Steroid-Skreen	35062203	FDA UDI	Class I	Unknown
Steroid-Skreen	35062009	FDA UDI	Class I	Unknown
Pregnancy-Skreen	Custom QC23	FDA UDI	Class I	Unknown
Detectabuse	18001419	FDA UDI	Class I	Active
Alere	88005	FDA UDI	Class I	Active
Detectabuse	18008246	FDA UDI	Class I	Active
Vma-Skreen	35071954	FDA UDI	Class I	Unknown
Express Check	18001264	FDA UDI	Class I	Active
Detectabuse	18000786	FDA UDI	Class I	Unknown
Detectabuse	18400040	FDA UDI	Class I	Unknown
Detectabuse	14100950	FDA UDI	Class I	Unknown
Salivabuse	55700	FDA UDI	Class I	Unknown
Detectabuse	19481340	FDA UDI	Class I	Active
Detectabuse	18000637	FDA UDI	Class I	Unknown
Detectabuse	14100620	FDA UDI	Class I	Unknown
Multi-Prep	14100920	FDA UDI	Class I	Unknown
Detectabuse	18008791	FDA UDI	Class I	Active
Steroid-Skreen	35066012	FDA UDI	Class I	Unknown
Detectabuse	18008334	FDA UDI	Class I	Active
Salivabuse	18200179	FDA UDI	Class I	Active
Detectabuse	Custom QC15	FDA UDI	Class I	Unknown
Steroid-Skreen	35063315	FDA UDI	Class I	Unknown
Detectabuse	Custom QC03	FDA UDI	Class I	Unknown
Multi-Prep	14200820	FDA UDI	Class I	Unknown
Pregnancy-Skreen	18000443	FDA UDI	Class I	Active
Detectabuse	18008473	FDA UDI	Class I	Active
Detectabuse	18030391	FDA UDI	Class I	Active
Detectabuse	18008052	FDA UDI	Class I	Active
Salivabuse	Custom QC11	FDA UDI	Class I	Unknown
Cenmed	2122017	FDA UDI	Class I	Active
Detectabuse	18400043	FDA UDI	Class I	Active
Salivabuse	18200005	FDA UDI	Class I	Active
Detectabuse	Custom QC16	FDA UDI	Class I	Unknown

BIOCHEMICAL DIAGNOSTICS INC

What BIOCHEMICAL DIAGNOSTICS INC makes

Frequently asked questions

Information

Catalogue (484)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Recalls (1)