Identity
- Trade Name
- LZI Oxycodone 300 Level 1 Control FDA UDI
- Generic Name
- Oxycodone IVD, control FDA UDI
- Device Name
- 5mL/bottle Concentration: 225 ng/mL of Oxycodone FDA UDI
- Model / Reference
- 0627 FDA UDI
- Description
- 5mL/bottle Concentration: 225 ng/mL of Oxycodone FDA UDI
Identifiers
- Catalog Number
- 0624 FDA UDI
- Primary DI / UDI-DI
- B07606270 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Oxycodone IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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, control
LZI Oxycodone 300 Level 1 Control by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxycodone IVD, control.
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- Pointe Oxycodone Control (375 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Emit II Plus Oxycodone Negative Control 100 — Siemens Healthcare Diagnostics · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Emit II Plus Oxycodone Positive Control 100 — Siemens Healthcare Diagnostics · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 1cebf254-cc43-4a0a-8836-2cf6094ad91d 35 fields · synced Jun 9, 2026