Identity
- Trade Name
- Alere iCup Dx Pro FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic Antidepressants with adulteration tests for Oxidant, pH and Specific Gravity. CLIA Waived Test Cup FDA UDI
- Model / Reference
- I-DXP-1117-01 FDA UDI
- Description
- Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic Antidepressants with adulteration tests for Oxidant, pH and Specific Gravity. CLIA Waived Test Cup FDA UDI
Identifiers
- Catalog Number
- I-DXP-1117-01 FDA UDI
- Primary DI / UDI-DI
- 00817405020300 FDA UDI
- 510(k) Number
- K082898 FDA UDI
- FDA Product Code
- NFW FDA UDINGL FDA UDINGG FDA UDINFY FDA UDINFV FDA UDINFT FDA UDIDIS FDA UDIDJR FDA UDILFG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3620 FDA UDI862.3910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Alere iCup Dx Pro by Instant Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082898 also covers:
- Alere iCup DX Pro — Instant Technologies, Inc.
- Alere iCup Dx Pro — Instant Technologies, Inc.
- Accutest — JANT PHARMACAL CORP.
- Accutest — JANT PHARMACAL CORP.
- Accutest — JANT PHARMACAL CORP.
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instant Technologies, Inc.
Sources (1)
- FDA UDI ff745b4e-913e-475d-970e-332d7c8c214f 37 fields · synced Jun 1, 2026