Identity
- Trade Name
- MGC Select DAU Control Set FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- MGC Select DAU Control Set EUDAMED
- Model / Reference
- 100202 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001633 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883001633 EUDAMED
- FDA Product Code
- DIF FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Multiple drugs of abuse 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
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
Category: Multiple drugs of abuse IVD, control
MGC Select DAU Control Set by Microgenics Corporation — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI 315062cf-3351-4446-a5fa-763ec55f6a5f 32 fields · synced Jun 19, 2026
- EUDAMED f1e0af94-fd4e-4357-ab06-7ce71e857717 61 fields · synced Jun 19, 2026