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DRI Barbiturate Serum Tox Assay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0911
Identity
- Trade Name
- DRI Barbiturate Serum Tox Assay FDA UDI
- Generic Name
- Barbiturate IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- DRI Barbiturate Serum Tox Assay EUDAMED
- Model / Reference
- 0911 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005587 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005587 EUDAMED
- 510(k) Number
- K960664 FDA UDI
- FDA Product Code
- DIS FDA UDI
- EMDN Code
- W0102090103 BARBITURATES EUDAMED
- GMDN Term
- Barbiturate IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3150 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
New Device
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DRI Barbiturate Serum Tox Assay 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-00884883005587 | 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 507dd370-2ad9-4843-992f-e1ce858a1b8d 61 fields · synced Jul 21, 2026
- FDA UDI 076b1e8a-910b-46b6-8ba1-a3b4b5304496 33 fields · synced May 30, 2026