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DRI pH-Detect pH 7.0 Control Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100284
Identity
- Trade Name
- DRI pH-Detect pH 7.0 Control Kit FDA UDI
- Generic Name
- Urine pH IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- DRI pH-Detect pH 7.0 Control Kit EUDAMED
- Model / Reference
- 100284 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005525 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005525 EUDAMED
- FDA Product Code
- JQY FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Urine pH IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 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
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 pH-Detect pH 7.0 Control Kit 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-00884883005525 | 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 7cfd72fa-de53-4972-96b0-3976d70b6538 61 fields · synced Jun 18, 2026
- FDA UDI 8763af32-5ace-4635-97ee-f0617860fa55 32 fields · synced May 29, 2026