Identity
- Trade Name
- Alere iCup Dx Pro 2 FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50 FDA UDI
- Model / Reference
- I-DXP-5A FDA UDI
- Description
- iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817405021055 FDA UDI
- 510(k) Number
- K133968 FDA UDI
- FDA Product Code
- LCM FDA UDILDJ FDA UDIDIO FDA UDIDJG FDA UDIDKZ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3250 FDA UDI862.3650 FDA UDI862.3100 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 2 by Instant Technologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K133968 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- Areta Multi-Drug Test Cup (10 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (50 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home COC Single Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (2 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
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 U | Pending data |
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Manufacturer
- Manufacturer
- Instant Technologies, Inc.
Sources (1)
- FDA UDI e63e7c7c-82b9-4663-99dd-2d83755999d4 36 fields · synced Jun 1, 2026