Identity
- Trade Name
- CLIAwaived FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) FDA UDI
- Model / Reference
- CLIA-RDTC-12-02 FDA UDI
- Description
- Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) FDA UDI
Identifiers
- Catalog Number
- CLIA-RDTC-12-02 FDA UDI
- Primary DI / UDI-DI
- 00816610020662 FDA UDI
- 510(k) Number
- K052115 FDA UDI
- FDA Product Code
- DKZ FDA UDILCM FDA UDILFG FDA UDIDJR FDA UDIDJG FDA UDIDJC FDA UDILDJ FDA UDIDIO FDA UDIDIS FDA UDIJXM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3910 FDA UDI862.3620 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3150 FDA UDI862.3170 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
CLIAwaived by Cliawaived, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052115 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Alere iCup Dx — Instant Technologies, Inc.
- Intelligent Transport Cup — NOBLE MEDICAL 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
- Cliawaived, Inc.
Sources (1)
- FDA UDI 3eafa31c-5f44-4344-aeb7-dbe4d2702a0d 37 fields · synced May 30, 2026