Identity
- Trade Name
- ENVOY 500 TOTAL BILIRUBIN REAGENT KIT FDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 55270 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800071 FDA UDI
- GMDN Term
- Total 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: Total bilirubin IVD, kit, spectrophotometry
Envoy 500 Total Bilirubin Reagent Kit by Vitalscientific — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitalscientific
Sources (2)
- FDA UDI 8bd5eebe-82f7-4331-8ccd-693f1ec190b2 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026