Identity
- Trade Name
- Alere iCup Dx 14 FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants with adulteration tests, Bleach, Creatinine, Nitrite, pH and Specific Gravity, CLIA Waived FDA UDI
- Model / Reference
- I-DXA-2147-011 FDA UDI
- Description
- Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants with adulteration tests, Bleach, Creatinine, Nitrite, pH and Specific Gravity, CLIA Waived FDA UDI
Identifiers
- Catalog Number
- I-DXA-2147-011 FDA UDI
- Primary DI / UDI-DI
- 00817405020027 FDA UDI
- 510(k) Number
- K122633 FDA UDI
- FDA Product Code
- LFH FDA UDILCM FDA UDIDJG FDA UDIDJC FDA UDILDJ FDA UDIDIO FDA UDIDKZ FDA UDIDIS FDA UDIJXM FDA UDIDJR FDA UDILAF FDA UDIJXN FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3620 FDA UDI862.3700 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
No
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 14 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
K122633 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- Coastline Explorer Cup — COASTLINE MEDICAL MANAGEMENT, LLC
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Alere iCUP DX — Instant Technologies, Inc.
- Alere iCUP DX — Instant Technologies, Inc.
- Alere iCup Dx 14 — Instant Technologies, Inc.
- Noble 1 Step + Cup — NOBLE MEDICAL INC
- Noble 1 Step Cup — NOBLE MEDICAL INC
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 dbfd9986-27d9-431f-a1e1-b79c12781e4f 37 fields · synced May 30, 2026