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Sign in to claim this brandNOBLE MEDICAL INC
US
Last updated May 23, 2026
What NOBLE MEDICAL INC makes
Noble Medical Inc manufactures in vitro diagnostic (IVD) devices for detecting multiple drugs of abuse, including rapid immunoassay test kits and clinical testing cups. Products include urine-based test cups with automated digital (AD) reading capabilities and dip cards, designed for point-of-care and clinical laboratory use.
The company’s portfolio is regulated under FDA Class II and Unclassified (U) device classifications, with devices listed in the FDA’s Unique Device Identifier (UDI) database. Noble Medical Inc 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 Noble Medical Inc manufacture?
Noble Medical Inc specializes in in vitro diagnostic (IVD) devices focused on detecting multiple drugs of abuse. Their products include rapid immunoassay test kits, clinical testing cups, and dip cards, primarily designed for urine-based testing. These devices are intended for point-of-care and clinical laboratory use, such as screening for substance abuse in various settings.
Where is Noble Medical Inc based, and how does that affect its regulatory oversight?
Noble Medical Inc is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA regulates these products to ensure safety, performance, and compliance with medical device standards. Since the company’s devices are classified as Class II or Unclassified (U), they undergo specific regulatory pathways to authorize their use in clinical settings.
Which regulatory registries or databases list Noble Medical Inc’s devices?
Noble Medical Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and improving patient safety by providing standardized identification for these products.
How are Noble Medical Inc’s devices classified by regulatory authorities?
Noble Medical Inc’s devices are classified under two regulatory categories by the FDA: Class II and Unclassified (U). Class II devices generally pose moderate risks and require special controls to ensure their safety and effectiveness, while Unclassified (U) devices are those that do not yet have a final classification but are still subject to regulatory review. These classifications determine the regulatory pathway and requirements for authorization.
What kinds of testing technologies do Noble Medical Inc’s devices use for drug of abuse detection?
Noble Medical Inc’s devices primarily use immunoassay technology for detecting drugs of abuse. This includes rapid test kits like the INSTA-SCREEN-2™ Cup and digital urine test cups with automated reading capabilities, such as the Noble Drug Test Cup with AD. These technologies are designed for quick, reliable, and often point-of-care results, making them useful for clinical and screening applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 035967806
Catalogue (81)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Noble | NM-DJO-197-291 | FDA UDI | Class II | Active |
| Intelligent Transport Cup | ITCA-12M-W | FDA UDI | Class II | Active |
| Noble | NM-DJA-147-341 | FDA UDI | Class II | Active |
| Noble Drug Test Cup with AD (Urine) | NMCupD-05-02-BT | FDA UDI | Class II | Active |
| Noble Drug Test Cup with AD (Urine) | E-NMCup-09-20-BT | FDA UDI | Class II | Active |
| Noble | NM-DJA-167-252 | FDA UDI | Class II | Active |
| INSTA-SCREEN-2TM Cup | IS2-DJO-2145L | FDA UDI | Class II | Active |
| Noble | NM-DJO-147-012 | FDA UDI | Class II | Active |
| INSTA-SCREEN-2TM Cup | IS2-DJO-154L | FDA UDI | Class II | Active |
| Noble Dip Card with AD (Urine) | E-NMCardA-05-18-BT | FDA UDI | Class II | Active |
| Noble | NM-DJO-1117-021 | FDA UDI | Class II | Active |
| Noble Drug Test Cup with AD (Urine) | NMCupC-12-75-BT | FDA UDI | U | Active |
| Noble | NM-DJO-177-161 | FDA UDI | Class II | Active |
| INSTA-SCREEN-2TM Cup | IS2-DJO-4104L | FDA UDI | Class II | Active |
| OralissTM Oral Fluid Drug Screen | DMDI-G810-003n | FDA UDI | Class II | Active |
| Noble | NM-DJA-1107-091 | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | NMCup-12-75 | FDA UDI | Class II | Active |
| Noble | NM-DJA-187-111 | FDA UDI | Class II | Active |
| OralissTM Oral Fluid Drug Screen | DMDI-G812-005N | FDA UDI | Class II | Active |
| Noble | NM-DJA-177-111 | FDA UDI | Class II | Active |
| OralissTM Oral Fluid Drug Screen | DMDI-G86-007N | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | NMCup-11-37-BT | FDA UDI | Class II | Active |
| Noble | NM-DJD-177-111 | FDA UDI | Class II | Active |
| Noble Dip Card with AD (Urine) | E-NMCardA-05-18 | FDA UDI | Class II | Active |
| Noble Dip Card (Urine) | NMCard-12-02-BT | FDA UDI | Class II | Active |
| OralissTM Oral Fluid Drug Screen | DMDI-G810-006N | FDA UDI | Class II | Active |
| Noble Dip Card (Urine) | NMCard-10-16-BT | FDA UDI | Class II | Active |
| OralissTM Oral Fluid Drug Screen | DMDI-G811-001n | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | E-NMCup-08-34 | FDA UDI | Class II | Active |
| Noble | NM-DJO-157-032 | FDA UDI | Class II | Active |
| Noble | NM-DJO-167-021 | FDA UDI | Class II | Active |
| Noble Dip Card (Urine) | NMCard-12-02-BT | FDA UDI | Class II | Unknown |
| Noble | NM-DJD-167-252 | FDA UDI | Class II | Active |
| Noble Drug Test Cup with AD (Urine) | E-NMCardA-10-51-BT | FDA UDI | Class II | Active |
| Noble | NM-DJA-157-831 | FDA UDI | Class II | Active |
| Noble | NM-DJA-157-691 | FDA UDI | Class II | Active |
| Noble Dip Card with AD (Urine) | E-NMCardA-10-51-BT | FDA UDI | Class II | Active |
| Noble | NM-DJO-167-1052 | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | NMCup-12-75-BT | FDA UDI | Class II | Active |
| Noble | NM-DJA-1107-232 | FDA UDI | Class II | Active |
| Noble | NM-DJA-147-012 | FDA UDI | Class II | Active |
| INSTA-SCREEN-2TM Cup | IS2-DJO-1137-300L | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | E-NMCup-11-25-BT | FDA UDI | Class II | Active |
| Noble Drug Test Cup (Urine) | NMCup-12-01-BT | FDA UDI | Class II | Active |
| Noble | NM-DJO-177-441 | FDA UDI | Class II | Active |
| Noble | NM-DJO-157-022 | FDA UDI | Class II | Active |
| Noble | NM-DJA-177-261 | FDA UDI | Class II | Active |
| INSTA-SCREEN-2TM Cup | IS2-DJA-1127-300L | FDA UDI | Class II | Active |
| Noble Drug Test Cup with AD (Urine) | E-NMCardA-10-51 | FDA UDI | Class II | Active |
| Noble | NM-DJA-1107-051 | FDA UDI | Class II | Active |
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