Identity
- Trade Name
- Mobile Phase EUDAMEDReagent FDA UDI
- Generic Name
- Multiple biogenic amine neurotransmitter IVD, reagent FDA UDI
- Device Name
- Mobile Phase EUDAMEDMobile Phase, L-DOPA, DHPG, DOPAC in plasma FDA UDI
- Model / Reference
- 5031 EUDAMEDFDA UDI
- Description
- Mobile Phase, L-DOPA, DHPG, DOPAC in plasma FDA UDI
Identifiers
- Catalog Number
- 5031 FDA UDI
- Primary DI / UDI-DI
- 04250317511409 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250317511409 EUDAMED
- FDA Product Code
- CHQ FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple biogenic amine neurotransmitter IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1165 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple biogenic amine neurotransmitter IVD, reagent
Reagent by Chromsystems Instruments & Chemicals GmbH — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
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
- Chromsystems Instruments & Chemicals GmbH
Sources (2)
- FDA UDI a2a961a2-e670-4f47-ab14-129518f0d64a 37 fields · synced Sep 17, 2026
- EUDAMED bea5dd4b-20b5-49b7-8424-9f32db98529b 61 fields · synced Sep 17, 2026