Identity
- Trade Name
- OXY Oxycodone FDA UDI
- Generic Name
- Oxycodone IVD, reagent FDA UDI
- Device Name
- DRI Oxycodone (200 tests) on COBAS INTEGRA and cobas c systems EUDAMED
- Model / Reference
- 08321248190 EUDAMED08321248 190 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613336154045 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07613336154045 EUDAMED
- 510(k) Number
- K040411 FDA UDI
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090123 OXYCODINE EUDAMED
- GMDN Term
- Oxycodone IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Oxycodone IVD, reagent
OXY Oxycodone by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K040411 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI f68844ef-0f83-428f-8a4e-ee684b138930 33 fields · synced Jul 16, 2026
- EUDAMED 2ca4e807-c7f5-4066-b3da-dfec0a7a92c8 61 fields · synced Jul 16, 2026