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Sign in to claim this brandBIOCHEMICAL DIAGNOSTICS INC
United States·US-MF-000025179
Last updated May 24, 2026
What BIOCHEMICAL DIAGNOSTICS INC makes
The company produces in vitro diagnostic (IVD) controls and reagents for detecting drugs of abuse in urine samples, including multi-panel tests for various substances. It also manufactures controls for ethanol (ETOH) testing and kits for measuring 17-hydroxycorticoid levels via spectrophotometry, alongside urine analyte controls and a human chorionic gonadotropin beta-core fragment test. Additional offerings include pregnancy screening tests and a device for monitoring vital signs.
These products fall under Class I and In Vitro Diagnostic (IVD) General device classifications, with regulatory listings in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification process, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biochemical Diagnostics Inc manufacture?
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.
Where is Biochemical Diagnostics Inc based, and what does that mean for regulatory oversight?
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.
How are the devices manufactured by Biochemical Diagnostics Inc classified under regulatory frameworks?
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.
Which regulatory registries list the devices made by Biochemical Diagnostics Inc?
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.
Why do some of the company’s devices appear under multiple names (e.g., Detectabuse vs. DETECTABUSE)?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 180, Heartland Blvd, Edgewood, United States
- Website
- www.kovaintl.com
- —
- —
- [email protected]
- Phone
- 6315959200
- PRRC Contact
- Amy Walsh
- EUDAMED SRN
- US-MF-000025179
- FDA FEI Number
- —
- DUNS Number
- 028007698
Catalogue (484)
Page 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Detectabuse | 18007861 | FDA UDI | Class I | Active |
| Detectabuse | 18003220 | FDA UDI | Class I | Active |
| Detectabuse | 14100720 | FDA UDI | Class I | Unknown |
| Steroid-Skreen | 35061011 | FDA UDI | Class I | Unknown |
| Monicheck | 18001001 | FDA UDI | Class I | Active |
| Detectabuse | 18008465 | FDA UDI | Class I | Active |
| Detectabuse | 18008289 | FDA UDI | Class I | Unknown |
| Detectabuse | 88003 | FDA UDI | Class I | Unknown |
| Salivabuse | 18200004 | FDA UDI | Class I | Active |
| Detectabuse | 180012V | FDA UDI | Class I | Active |
| Detectabuse | 52230 | FDA UDI | Class I | Active |
| Detectabuse | 18000696 | FDA UDI | Class I | Active |
| Detectabuse | 18007797 | FDA UDI | Class I | Active |
| Cenmed | 2110005 | FDA UDI | Class I | Active |
| Detectabuse | Custom QC06 | FDA UDI | Class I | Unknown |
| Cenmed | 2110007 | FDA UDI | Class I | Active |
| Multi-Prep | 14100327 | FDA UDI | Class I | Unknown |
| Pregnancy-Skreen | Custom QC31 | FDA UDI | Class I | Unknown |
| Salivabuse | 20200011 | FDA UDI | Class I | Unknown |
| Vma-Skreen | 35071407 | FDA UDI | Class I | Unknown |
| Detectabuse | 18003103 | FDA UDI | Class I | Active |
| Detectabuse | 18030362 | FDA UDI | Class I | Active |
| Detectabuse | 19481350 | FDA UDI | Class I | Active |
| Vma-Skreen | 35071377 | FDA UDI | Class I | Unknown |
| Detectabuse | 18030395 | FDA UDI | Class I | Active |
| Detectabuse | 18003276 | FDA UDI | Class I | Active |
| Detectabuse | 18008256 | FDA UDI | Class I | Unknown |
| Vma-Skreen | 35071351 | FDA UDI | Class I | Unknown |
| Detectabuse | 88000 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008050 | FDA UDI | Class I | Active |
| Detectabuse | Custom QC13 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008289 | FDA UDI | Class I | Active |
| Detectabuse | 18007710 | FDA UDI | Class I | Active |
| Detectabuse | Custom QC07 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008255 | FDA UDI | Class I | Active |
| Steroid-Skreen | 35061401 | FDA UDI | Class I | Unknown |
| Detectabuse | 18007569 | FDA UDI | Class I | Active |
| Steroid-Skreen | 35066403 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008623 | FDA UDI | Class I | Active |
| Salivabuse | 18200178 | FDA UDI | Class I | Active |
| Multi-Prep | 14030012 | FDA UDI | Class I | Unknown |
| Detectabuse | 18003217 | FDA UDI | Class I | Active |
| Vma-Skreen | 35071253 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008662 | FDA UDI | Class I | Active |
| Detectabuse | 18001424 | FDA UDI | Class I | Active |
| Detectabuse | 18003221 | FDA UDI | Class I | Active |
| Steroid-Skreen | 35061835 | FDA UDI | Class I | Unknown |
| Steroid-Skreen | 35066612 | FDA UDI | Class I | Unknown |
| Detectabuse | 18008661 | FDA UDI | Class I | Active |
| Alere | 88004 | FDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biochemical Diagnostics Inc. has one recall record initiated on 2015-09-14, which is marked as terminated. The recall pertains to CONSULT diagnostics hCG Controls, where discrepancies were noted between the storage temperatures listed on the kit labels and those on the individual vial labels and the package insert.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 14, 2015 | Z-0328-2016 | — | terminated | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. |