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Sign in to claim this brandMICRO DISTRIBUTING, L.C
US
Last updated May 24, 2026
What MICRO DISTRIBUTING, L.C makes
Micro Distributing, L.C. manufactures in vitro diagnostic (IVD) devices for detecting drugs of abuse, including rapid immunochromatographic tests (ICT) and clinical kits. Their portfolio includes tests for methamphetamine, benzodiazepines, cocaine and its metabolites, methadone, morphine and its metabolites, oxycodone, and phencyclidine (PCP). These products are designed for point-of-care and laboratory use, providing results in formats such as cups, dipsticks, and swabs.
The company’s devices fall under FDA Class II and Unclassified (U) regulatory categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Their portfolio is regulated under U.S. medical device laws, ensuring compliance with FDA requirements for diagnostic testing accuracy and safety. The manufacturer operates within the United States, adhering to domestic regulatory standards for IVD products.
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 Micro Distributing, L.C. manufacture?
Micro Distributing, L.C. specializes in in vitro diagnostic (IVD) devices focused on detecting drugs of abuse. Their portfolio includes rapid immunochromatographic tests (ICT) and clinical kits for identifying substances like methamphetamine, benzodiazepines, cocaine and its metabolites, methadone, morphine and its metabolites, oxycodone, and phencyclidine (PCP). These devices are designed for both point-of-care and laboratory use, offering formats such as cups, dipsticks, and swabs for quick and convenient testing.
Where is Micro Distributing, L.C. based, and how does this affect its regulatory oversight?
Micro Distributing, L.C. is based in the United States, which means its devices are subject to U.S. medical device regulations. Since these are IVD products, they fall under the jurisdiction of the FDA, ensuring compliance with U.S. standards for diagnostic accuracy, safety, and performance. The company’s location also influences which regulatory databases and requirements apply to its products, such as the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries or databases list Micro Distributing, L.C.’s devices?
Micro Distributing, L.C.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify and track the devices’ identification, manufacturing details, and compliance status under U.S. regulations.
How are Micro Distributing, L.C.’s devices classified under FDA regulations?
Micro Distributing, L.C.’s IVD devices are classified under two categories: Class II and Unclassified (U). Class II devices generally require special controls to ensure their safety and effectiveness, while Unclassified devices may have less stringent regulatory pathways but still must meet FDA requirements for performance and labeling. The classification determines the level of scrutiny and regulatory oversight each device undergoes before entering the market.
What kinds of substances do Micro Distributing, L.C.’s devices test for, and why is this important?
Micro Distributing, L.C.’s devices test for a range of drugs of abuse, including methamphetamine, benzodiazepines, cocaine and its metabolites, methadone, morphine and its metabolites, oxycodone, and phencyclidine (PCP). This focus is critical for clinical, forensic, and emergency settings where rapid and accurate detection of these substances is essential for patient care, public safety, or legal proceedings. Their rapid ICT and clinical kit formats enable quick results, which are vital in time-sensitive scenarios.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- micro-distributing.com
- —
- —
- [email protected]
- Phone
- 866-933-0964
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 087732173
Catalogue (201)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Statcup® Ii | STATII-4267-0-A | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-1257-0-A | FDA UDI | Class II | Active |
| Statswab® | SSB-188 | FDA UDI | Class II | Active |
| Fastest Labs | FST-4267 | FDA UDI | Class II | Active |
| Statcup® | SCP-51127-A | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-83127 | FDA UDI | Class II | Active |
| Statcup® | SCP-61107-A-E | FDA UDI | Class II | Unknown |
| Statcup® Ii | STATⅡ-6167-A-CR | FDA UDI | Class II | Active |
| STATTEST Home Pregnancy Test | STP-10-0 | FDA UDI | Class II | Active |
| Statdip® | SDP-354-0 | FDA UDI | U | Active |
| Statcup® | SCP-2167-0 | FDA UDI | Class II | Active |
| Statdip® | DMO-114-0 | FDA UDI | Class II | Active |
| Statcup® | SCP-1387-A | FDA UDI | Class II | Active |
| Statdip® | SDP-384 | FDA UDI | Class II | Active |
| Statcup® Ii | STATII-71127-A | FDA UDI | N/A | Active |
| Statcup® | SCP-31107-0-A | FDA UDI | Class II | Active |
| Statdip® | SDP-564 | FDA UDI | U | Active |
| Statcup® | SCP-51127-0-A | FDA UDI | Class II | Active |
| Statdip® | SDP-2114-0 | FDA UDI | U | Active |
| Statcup® | SCP-1257 | FDA UDI | Class II | Active |
| Statswab® | SSB-368 | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-71127-0 | FDA UDI | Class II | Active |
| Statcup® | SCP-2397-0-A | FDA UDI | Class II | Active |
| Statcassette® | SCS-2145 | FDA UDI | Class II | Active |
| Statdip® | SDP-464-0 | FDA UDI | Class II | Active |
| Statcup® Ii | STATII-83127-A | FDA UDI | Class II | Active |
| Statdip® | SDP-234-0 | FDA UDI | Class II | Active |
| Statcup® Ii | STAII-03107-0-A | FDA UDI | Class II | Active |
| Statcup® Ii | STATII-4267-0 | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-1257 | FDA UDI | Class II | Active |
| Statdip® | SDP-154 | FDA UDI | U | Active |
| Statcup® | SCP-21107-A | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-13147-0-A | FDA UDI | Class II | Active |
| Statdip® | DBA-114-0 | FDA UDI | Class II | Active |
| Statswabii® | SWABII-368 | FDA UDI | Class II | Active |
| Statdip® | DOX-114-0 | FDA UDI | Class II | Active |
| Statdip® | SDP-1104 | FDA UDI | Class II | Active |
| Statswab® | SSB-4108 | FDA UDI | Class II | Active |
| Statswab3 | SS3-048 | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-41107-0-A | FDA UDI | Class II | Active |
| Statdip® | DOX-114 | FDA UDI | Class II | Active |
| Statcup® Ii | STATII-71127-A-CR | FDA UDI | N/A | Active |
| Statcup® | SCP-21107 | FDA UDI | Class II | Active |
| Statdip® | DPP-114-0 | FDA UDI | Class II | Active |
| Statcup® | SCP-1257-0 | FDA UDI | Class II | Active |
| Statcup® Ii | STATⅡ-12107-0-A | FDA UDI | Class II | Active |
| Statcup® | SCP-2167-A | FDA UDI | Class II | Active |
| Statdip® | SDP-234 | FDA UDI | Class II | Active |
| Statdip® | SDP-044 | FDA UDI | Class II | Active |
| Statdip® | DBA-114 | FDA UDI | Class II | Active |
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