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DRI Opiate Urine Calibrator 1
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 1609
Identity
- Trade Name
- DRI Opiate Urine Calibrator 1 FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, calibrator FDA UDI
- Device Name
- DRI Opiate Urine Calibrator 1 EUDAMED
- Model / Reference
- 1609 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005297 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005297 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090113 OPIATES EUDAMED
- GMDN Term
- Opiate/opiate metabolite IVD, calibrator 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DRI Opiate Urine Calibrator 1 by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883005297 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED eef5e66c-bb0e-4f85-b74e-fba1615e251c 61 fields · synced Jun 19, 2026
- FDA UDI 9fcf38ce-12b0-44c3-90c5-2c21029d5ee3 32 fields · synced May 29, 2026