Identity
- Trade Name
- ENVOY 500 ALBUMIN REAGENT KIT FDA UDI
- Generic Name
- Albumin IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 55225 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800019 FDA UDI
- GMDN Term
- Albumin IVD, kit, spectrophotometry 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Albumin IVD, kit, spectrophotometry
Envoy 500 Albumin Reagent Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, kit, spectrophotometry.
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- Albumin Gen.2 — Roche Diagnostics Corp. · Class II
- Pointe Scientific, Inc. Albumin — POINTE SCIENTIFIC, INC. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Synchron — Beckman Coulter, Inc. · 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
- Vitalscientific
Sources (1)
- FDA UDI 34959fd1-71fc-4d49-8a97-983987722fe7 32 fields · synced May 30, 2026