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ProLyte Electrolyte Analyzer
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref 0-DD-PROLYTE
Identity
- Trade Name
- ProLyte Electrolyte Analyzer FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- ProLyte Electrolyte Analyzer EUDAMEDThe Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases involving electrolyte imbalance. FDA UDI
- Model / Reference
- 0-DD-PROLYTE EUDAMEDFDA UDI
- Description
- The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases involving electrolyte imbalance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403019984 EUDAMEDFDA UDI
- Basic UDI-DI
- 0811403010DDPROLYTEQY EUDAMED
- FDA Product Code
- JGS FDA UDICEM FDA UDICGZ FDA UDIJIH FDA UDIJJE FDA UDI
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
- GMDN Term
- Ion-selective analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1600 FDA UDI862.1170 FDA UDI862.3560 FDA UDI862.2160 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
ProLyte Electrolyte Analyzer by DIAMOND DIAGNOSTICS Inc — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102959 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K121140 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K070104 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0811403010DDPROLYTEQY | Class A | Active |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (3)
- EUDAMED 1de52c2b-6901-4143-b223-2660a89d7a54 61 fields · synced Jul 10, 2026
- FDA UDI f89d2e7b-435c-4aa0-b82a-f28241879475 33 fields · synced May 29, 2026
- FDA 510(k) K102959 1 fields · synced May 18, 2026