Identity
- Trade Name
- Noble 1 Step Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived) FDA UDI
- Model / Reference
- NBCA-7C-W FDA UDI
- Description
- Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived) FDA UDI
Identifiers
- Catalog Number
- NBCA-7C-W FDA UDI
- Primary DI / UDI-DI
- 00858886006308 FDA UDI
- 510(k) Number
- K052115 FDA UDI
- FDA Product Code
- DJG FDA UDIJXM FDA UDIDKZ FDA UDILCM FDA UDILDJ FDA UDIDIO FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3870 FDA UDI862.3250 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
Noble 1 Step Cup by Noble Medical Inc — Class II — 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
K052115 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- 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
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
- Noble Medical Inc
Sources (1)
- FDA UDI 45e25e46-0799-4ff4-97d8-1446b320e423 36 fields · synced Jun 8, 2026