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Sign in to claim this brandEXPRESS DIAGNOSTICS INT'L, INC.
US
Last updated May 24, 2026
What EXPRESS DIAGNOSTICS INT'L, INC. makes
Express Diagnostics International, Inc. manufactures rapid immunoassay kits for detecting multiple drugs of abuse in clinical and point-of-care settings. These devices are designed for immediate testing, including intravenous drug testing and clinical screening, to identify substances such as opioids, stimulants, and other controlled compounds.
The company’s products are classified under FDA’s Class II and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in 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 Express Diagnostics International, Inc. manufacture?
Express Diagnostics International, Inc. specializes in rapid immunoassay kits designed for detecting multiple drugs of abuse. These devices are primarily used in clinical and point-of-care settings, including intravenous drug testing and rapid screening. The kits are intended for immediate results, helping healthcare providers quickly identify substances like opioids, stimulants, and other controlled compounds.
Where is Express Diagnostics International, Inc. based?
The company is headquartered in the United States. This location allows it to comply with U.S. regulatory requirements, including those for medical devices intended for domestic and international markets.
Which regulatory registries or databases list Express Diagnostics International, Inc.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details and compliance.
How are Express Diagnostics International, Inc.’s devices classified by the FDA?
The company’s products fall under FDA’s Class II and Unclassified (U) categories. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Unclassified devices are typically low-risk and subject to general controls. Classification helps determine the regulatory pathway and oversight required for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- drugcheck.com
- —
- —
- [email protected]
- Phone
- 507-526-3951
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 168560402
Catalogue (819)
Page 7 of 17| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DrugCheck | 60506 | FDA UDI | Class II | Unknown |
| DrugCheck | 30111 | FDA UDI | Class II | Unknown |
| DrugCheck | 61104 | FDA UDI | Class II | Unknown |
| DrugCheck | 71020 | FDA UDI | Class II | Active |
| DrugCheck | 31103 | FDA UDI | Class II | Unknown |
| DrugCheck | 30702 | FDA UDI | Class II | Unknown |
| DrugCheck | 61007-5 | FDA UDI | Class II | Active |
| DrugCheck | 60700 | FDA UDI | Class II | Unknown |
| DrugCheck | 30602 | FDA UDI | Class II | Unknown |
| DrugCheck | 61202-3 | FDA UDI | Class II | Unknown |
| DrugCheck | 61211 | FDA UDI | Class II | Active |
| DrugCheck | 30713 | FDA UDI | Class II | Active |
| DrugCheck | 30605 | FDA UDI | Class II | Unknown |
| DrugCheck | 30206-3 | FDA UDI | Class II | Unknown |
| DrugCheck | 61021 | FDA UDI | U | Unknown |
| DrugCheck | 61106 | FDA UDI | Class II | Unknown |
| DrugCheck | 30170 | FDA UDI | Class II | Unknown |
| DrugCheck | 60505-3 | FDA UDI | Class II | Active |
| DrugCheck | 30150C | FDA UDI | Class II | Unknown |
| DrugCheck | 60410 | FDA UDI | Class II | Unknown |
| DrugCheck | 30903-3 | FDA UDI | Class II | Unknown |
| DrugCheck | 60915 | FDA UDI | Class II | Active |
| DrugCheck | 30130C | FDA UDI | Class II | Active |
| DrugCheck | 60788 | FDA UDI | Class II | Unknown |
| DrugCheck | 30140C | FDA UDI | Class II | Unknown |
| DrugCheck | 61129-5 | FDA UDI | Class II | Active |
| DrugCheck | 30970 | FDA UDI | Class II | Unknown |
| DrugCheck | 31207-3 | FDA UDI | Class II | Unknown |
| DrugCheck | 31045-3 | FDA UDI | Class II | Unknown |
| DrugCheck | 61024 | FDA UDI | Class II | Unknown |
| DrugCheck | 31109 | FDA UDI | Class II | Active |
| DrugCheck | 31082 | FDA UDI | Class II | Unknown |
| DrugCheck | 30434 | FDA UDI | Class II | Unknown |
| DrugCheck | 30140 | FDA UDI | Class II | Unknown |
| DrugCheck | 30690 | FDA UDI | Class II | Active |
| DrugCheck | 60936 | FDA UDI | Class II | Active |
| DrugCheck | 30110C | FDA UDI | Class II | Active |
| DrugCheck | 30300 | FDA UDI | Class II | Active |
| DrugCheck | 60921 | FDA UDI | Class II | Unknown |
| DrugCheck | 30807 | FDA UDI | Class II | Active |
| DrugCheck | 31015-6 | FDA UDI | Class II | Active |
| DrugCheck | 30120C | FDA UDI | Class II | Unknown |
| DrugCheck | 60890-5 | FDA UDI | Class II | Unknown |
| DrugCheck | 60930 | FDA UDI | Class II | Active |
| DrugCheck | 61201-3 | FDA UDI | Class II | Active |
| DrugCheck | 65515-5 | FDA UDI | Class II | Active |
| DrugCheck | 30309 | FDA UDI | Class II | Unknown |
| DrugCheck | 30510 | FDA UDI | Class II | Active |
| DrugCheck | 30204 | FDA UDI | U | Unknown |
| DrugCheck | 61021-5 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Express Diagnostics Int'l, Inc. has four recall records listed in the FDA database, all initiated between October 4, 2010, and November 21, 2014, with each classified as terminated. The recalls involved DrugCheck devices and related components, citing reasons including potential false positive results for Ketamine screening, incorrect expiration dating leading to improper functionality, non-compliance with 510(k) clearance for certain alcohol test strips, and mislabeling of DrugCheck Drug Screen Cups containing buprenorphine and propoxyphene as unsuitable for diagnostic or treatment use in the U.S.
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 |
|---|---|---|---|---|
| Nov 21, 2014 | Z-1033-2015 | — | terminated | This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results. |
| Mar 18, 2011 | Z-2387-2011 | — | terminated | Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results. |
| Nov 1, 2010 | Z-3104-2011 | — | terminated | Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could not be labeled as such in the US. |
| Oct 4, 2010 | Z-3113-2011 | — | terminated | Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States. |