Identity
- Trade Name
- CLIAwaived FDA UDI
- Generic Name
- Oxycodone IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Single Drug Dipstick Test for OXY100 FDA UDI
- Model / Reference
- CLIA-SDDT-23 FDA UDI
- Description
- Single Drug Dipstick Test for OXY100 FDA UDI
Identifiers
- Catalog Number
- CLIA-SDDT-23 FDA UDI
- Primary DI / UDI-DI
- 00816610020259 FDA UDI
- 510(k) Number
- K022355 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Oxycodone IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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: Oxycodone IVD, kit, rapid ICT, clinical
A rapid and convenient single-drug dipstick test for detecting oxycodone in clinical specimens using an immunochromatographic test (ICT) method. This reliable device is designed for point-of-care analysis, eliminating the need for laboratory testing.
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Also classified as Oxycodone IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K022355 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cliawaived, Inc.
Sources (1)
- FDA UDI ea318ef0-3345-469f-80f4-edbeed57972c 37 fields · synced Jun 22, 2026