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 (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG FDA UDI
- Model / Reference
- CLIA-14-RDTC-A FDA UDI
- Description
- Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG FDA UDI
Identifiers
- Catalog Number
- CLIA-14-RDTC-A FDA UDI
- Primary DI / UDI-DI
- 00816610020082 FDA UDI
- 510(k) Number
- K122633 FDA UDI
- FDA Product Code
- DJR FDA UDIDIS FDA UDIJXN FDA UDILCM FDA UDILFG FDA UDIJXM FDA UDIDKZ FDA UDIDJC FDA UDIDJG FDA UDIDIO FDA UDILDJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3150 FDA UDI862.3700 FDA UDI862.3910 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3250 FDA UDI862.3870 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
K122633 also covers:
- 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.
- 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
- Cliawaived, Inc.
Sources (1)
- FDA UDI 4ba354a2-7b43-48ed-a94b-da306b53bf09 37 fields · synced May 29, 2026