Identity
- Trade Name
- ENVOY 500 DIRECT BILIRUBIN REAGENT KIT FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 55260 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800064 FDA UDI
- GMDN Term
- Conjugated (direct) bilirubin 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: Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Envoy 500 Direct Bilirubin Reagent Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conjugated (direct) bilirubin IVD, kit, spectrophotometry.
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- DIRECT BILIRUBIN-SL Assay — Sekisui Diagnostics, LLC · Class II
- Atellica CH DBil_2 — Siemens Healthcare Diagnostics · Class II
- DBIL Reagent Kit — Medica Corp. · Class II
- Advanced Instruments BR2 Hydrochloric Acid — Advanced Instruments, LLC · Class II
- Advanced Instruments BR2 Sulfanilic Acid — Advanced Instruments, LLC · 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 703b4861-14d3-4a34-8f17-253ec52249d4 32 fields · synced May 30, 2026