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Sign in to claim this brandInstant Technologies, Inc.
US
Last updated May 24, 2026
What Instant Technologies, Inc. makes
Instant Technologies, Inc. manufactures in vitro diagnostic (IVD) devices for detecting drugs of abuse and their metabolites, including kits and rapid immunoassay tests for clinical and point-of-care use. Products cover opiates, cannabinoids, cocaine, methamphetamine, morphine, and oxycodone, as well as calibrators for multi-drug screening. The portfolio includes both single-target and multi-drug testing formats, designed for rapid results in settings like emergency rooms, law enforcement, and medical facilities.
The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories, with all products listed in the FDA’s UDI (Unique Device Identification) database. The manufacturer is based in the United States, adhering to U.S. regulatory requirements for IVD authorization.
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 Instant Technologies, Inc. manufacture?
Instant Technologies, Inc. specializes in in vitro diagnostic (IVD) devices focused on detecting drugs of abuse and their metabolites. Their portfolio includes rapid immunoassay tests, kits, and calibrators for clinical and point-of-care use. These devices target substances like opiates, cannabinoids, cocaine, methamphetamine, morphine, and oxycodone, often providing results quickly for settings such as emergency rooms, medical facilities, or law enforcement.
Where is Instant Technologies, Inc. based, and does that affect its regulatory approach?
Instant Technologies, Inc. is based in the United States. As a U.S.-based manufacturer, the company develops its IVD devices in compliance with U.S. regulatory requirements, including those set by the FDA. This means their products are designed and authorized under the FDA’s regulatory framework, which governs classification, listing, and labeling for medical devices in the U.S. market.
How are Instant Technologies, Inc.’s devices classified by the FDA, and why does this matter?
Instant Technologies, Inc.’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories. Classification determines the regulatory controls applied to a device: Class I generally involves general controls, Class II requires special controls, and Unclassified devices may undergo a case-by-case review. This classification helps ensure appropriate oversight based on the device’s risk level, with higher-risk devices requiring more stringent authorization processes.
Are Instant Technologies, Inc.’s devices listed in any regulatory registries, and if so, which ones?
Yes, Instant Technologies, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system assigns a unique identifier to each device, improving tracking, traceability, and transparency in the medical device supply chain. Listing in this registry helps healthcare providers, regulators, and other stakeholders verify the identity of the device and access critical information like manufacturing details and regulatory status.
What kinds of testing formats do Instant Technologies, Inc.’s devices support, and how are they used?
Instant Technologies, Inc.’s devices include rapid immunoassay tests (like kits and point-of-care formats), calibrators for multi-drug screening, and formats such as cassettes, cups, and screens. These formats are designed for flexibility: rapid tests (e.g., iCup™ or iScreen™) provide results quickly in clinical or field settings, while calibrators ensure accuracy in multi-drug testing. The variety allows for use in diverse environments, from emergency rooms to law enforcement or medical laboratories, depending on the specific device’s intended purpose.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- abbott.com
- —
- —
- [email protected]
- Phone
- 1-800-340-4029
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 019410187
Catalogue (411)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AlereTM iScreen® | IS5MB | FDA UDI | Class II | Active |
| iCup™ | DOA-1137-011 | FDA UDI | Class II | Active |
| iScreen™ | ABTDOAK15701A | FDA UDI | Class II | Active |
| AlereTM iScreen® | IS1TCA | FDA UDI | Class II | Active |
| iScreen™ | DOA-1114-111 | FDA UDI | Class II | Active |
| iScreen™ | DOA-154-071 | FDA UDI | Class II | Active |
| Alere iScreen Dx | IS1 AMP-DX | FDA UDI | Class II | Active |
| Alere iScreen Dx | IS12-DX | FDA UDI | Class II | Active |
| iScreen™ | DOA-134-951 | FDA UDI | Class II | Active |
| iCup™ | DUA-167-012 | FDA UDI | Class II | Active |
| iCup® | i-DOA-11107 | FDA UDI | Class II | Active |
| iCassette™ | DOX-102 | FDA UDI | Class II | Active |
| iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | DUE-187-311 | FDA UDI | Class II | Active |
| AlereTM iScreen® | IS4A | FDA UDI | Class II | Active |
| iCup® | I-DUA-187-012 | FDA UDI | Class II | Active |
| iCassette™ | DOP-102 | FDA UDI | Class II | Active |
| iScreen™ | ABTDOAW14701A | FDA UDI | Class II | Active |
| iCup® | I-DUD-1107-012 | FDA UDI | Class II | Active |
| iScreen™ | DMT-114 | FDA UDI | Class II | Active |
| iScreen™ | DOA-164-1481 | FDA UDI | Class II | Active |
| ProScreen | PSCupA-10OM | FDA UDI | Class II | Unknown |
| iScreen™ | DOP-114 | FDA UDI | Class II | Active |
| AlereTM iCassette® | I-DOA-1165 | FDA UDI | Class II | Active |
| T-Cup® Compact | ACDOA-7125 | FDA UDI | Class II | Active |
| iScreen™ | ABTDUAW113701A | FDA UDI | Class II | Active |
| iCup™ | DUE-197-261 | FDA UDI | Class II | Active |
| UScreen® | USSCupA-10M | FDA UDI | Class II | Active |
| T-Cube® | Tcube-6MB | FDA UDI | Class II | Active |
| Alere iCup Dx Pro 2 | I-DXP-10 | FDA UDI | Class II | Active |
| AlereTM iCassette® | I-DOA-1145 | FDA UDI | Class II | Active |
| iScreen™ | DOA-144-071 | FDA UDI | Class II | Active |
| iScreen™ | DOA-124-311 | FDA UDI | Class II | Active |
| iScreen™ | DOA-154-201 | FDA UDI | Class II | Active |
| iScreen™ | ABTOFCUBE0903C | FDA UDI | Class II | Active |
| iScreen™ | DOA-124-031 | FDA UDI | Class II | Active |
| iCassette | ABTDFYW11201A | FDA UDI | Class II | Active |
| iScreen™ | DOA-164-1551 | FDA UDI | Class II | Active |
| AlereTM iScreen® | I-DUE-164-161 | FDA UDI | Class II | Active |
| iScreen™ | ABTOFCUBE0501A | FDA UDI | Class II | Active |
| UScreen® | USSCupA-11CLIALC | FDA UDI | Class II | Active |
| iScreen™ | DOA-154-021 | FDA UDI | Class II | Active |
| T-Cube® | TCUBE-9DBA | FDA UDI | Class II | Active |
| T-Cube® | TCUBE-6ME | FDA UDI | Class II | Active |
| iScreen™ | ABTOFCUBE0502B | FDA UDI | Class II | Active |
| iCup® | I-DOA-1137-011 | FDA UDI | Class II | Active |
| ProScreen | PSCupA-6MB-W | FDA UDI | Class II | Unknown |
| T-Cup® | TDOA-7A | FDA UDI | U | Active |
| Alere iCup Dx Pro | I-DXP-1117-01 | FDA UDI | Class II | Active |
| iScreen™ | DMA-114 | FDA UDI | Class II | Active |
| iScreen™ | ABTDOAW111701A | FDA UDI | U | Active |
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