Identity
- Trade Name
- Pointe Oxycodone Reagent Set FDA UDI
- Generic Name
- Oxycodone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Oxycodone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-OX0480-1L FDA UDI
- Description
- Pointe Oxycodone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-OX0480-1L FDA UDI
- Primary DI / UDI-DI
- 00811727017451 FDA UDI
- 510(k) Number
- K120763 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Oxycodone IVD, kit, enzyme immunoassay (EIA) 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
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, kit, enzyme immunoassay (EIA)
Pointe Oxycodone Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 DAU Calibrator, Low 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.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 545e77f1-144e-4ffe-8eb6-a7d68db379eb 37 fields · synced Jun 1, 2026