Identity
- Trade Name
- Urine Diluent FDA UDI
- Generic Name
- Multiple electrolyte IVD, reagent FDA UDI
- Model / Reference
- TB-20270482D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403018604 FDA UDI
- GMDN Term
- Multiple electrolyte IVD, reagent FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 electrolyte IVD, reagent
Urine Diluent by DIAMOND DIAGNOSTICS Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple electrolyte IVD, reagent.
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- Dimension® QuikLYTE® Multisensor Flush Solution — Siemens Healthcare Diagnostics · Class II
- Atellica IMT Dilution Check — Siemens Healthcare Diagnostics · Class I
- Dimension Vista® V-LTYE® Dilution Check — Siemens Healthcare Diagnostics · Class II
- Dimension® QuikLYTE® Integrated Multisensor Sample Diluent — Siemens Healthcare Diagnostics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- DIAMOND DIAGNOSTICS Inc
Sources (1)
- FDA UDI df95343b-8465-4c6e-940b-db4ef2ac68e0 32 fields · synced May 30, 2026