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DRI Hydrocodone Assay Control Kit (2 x 10 mL)
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 10018149
Identity
- Trade Name
- DRI Hydrocodone Controls FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, control FDA UDI
- Device Name
- DRI Hydrocodone Assay Control Kit (2 x 10 mL) EUDAMED
- Model / Reference
- 10018149 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883000360 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883000360 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102090113 OPIATES EUDAMED
- GMDN Term
- Opiate/opiate metabolite IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 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
No
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 Hydrocodone Assay Control Kit (2 x 10 mL) by Microgenics Corporation — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173195 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00884883000360 | Class IVD General | Active |
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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 (3)
- EUDAMED b45cd9a1-b893-4d36-a2f9-cfb0de1714bc 61 fields · synced Jul 14, 2026
- FDA UDI 2fa802a9-9a32-4675-9809-e8d28753c9ac 32 fields · synced May 30, 2026
- FDA 510(k) K173195 1 fields · synced May 18, 2026