Identity
- Trade Name
- ENVOY 500 ISE REFERENCE SOLUTION KIT FDA UDI
- Generic Name
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
- Model / Reference
- 55382 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800224 FDA UDI
- GMDN Term
- Ion selective electrode (ISE) reference solution 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: Ion selective electrode (ISE) reference solution IVD, reagent
Envoy 500 Ise Reference Solution Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Vitalscientific
Sources (1)
- FDA UDI d71b85dc-fde2-40e2-a302-85c8db74dbd3 32 fields · synced May 30, 2026