Identity
- Trade Name
- Oxycodone DAU Calibrator, Low Calibrator FDA UDI
- Generic Name
- Oxycodone IVD, calibrator FDA UDI
- Device Name
- 5mL/bottle. Concentration: 50 ng/mL of Oxycodone. FDA UDI
- Model / Reference
- 0252b FDA UDI
- Description
- 5mL/bottle. Concentration: 50 ng/mL of Oxycodone. FDA UDI
Identifiers
- Catalog Number
- 0252b FDA UDI
- Primary DI / UDI-DI
- B0760252B0 FDA UDI
- 510(k) Number
- K120763 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Oxycodone IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
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, calibrator
Oxycodone DAU Calibrator, Low Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oxycodone IVD, calibrator.
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Cleared under the same submission
K120763 also covers:
- Oxycodone 100 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Oxycodone 100 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Oxycodone 300 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Oxycodone 300 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Oxycodone DAU Calibrator, Cutoff Calibrator #1 — Lin-Zhi International, Inc.
- Oxycodone DAU Calibrator, Cutoff Calibrator #2 — Lin-Zhi International, Inc.
- Oxycodone DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oxycodone DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Oxycodone Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oxycodone Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Oxycodone Calibrator (100 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Oxycodone Calibrator (300 ng/mL) — POINTE SCIENTIFIC, 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 09211c23-2d4b-4236-8938-cd88f69458fa 36 fields · synced Jun 9, 2026