Identity
- Trade Name
- ENVOY 500 CALCIUM REAGENT KIT FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 55287 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540201400 FDA UDI
- GMDN Term
- Calcium (Ca2+) 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: Calcium (Ca2+) IVD, kit, spectrophotometry
Envoy 500 Calcium Reagent Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CALCIUM Assay — Sekisui Diagnostics, LLC · Class II
- CALCIUM (Ca) — Randox Laboratories, Ltd. · Class II
- Calcium Gen2 — Roche Diagnostics Corp. · Class II
- Atellica CH Ca — 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
- Vitalscientific
Sources (1)
- FDA UDI c6bbfeae-d960-4a29-9f42-c9860caf29d8 32 fields · synced May 30, 2026