Identity
- Trade Name
- ENVOY 500 HDL CALIBRATOR KIT FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
- Model / Reference
- 55119 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800170 FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, calibrator 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: High density lipoprotein (HDL) cholesterol IVD, calibrator
Envoy 500 Hdl Calibrator Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, calibrator.
- AU — Beckman Coulter, Inc. · Class II
- Atellica CH HDLC CAL — Siemens Healthcare Diagnostics · Class II
- Ultra N-geneous HDL Cholesterol Calibrator — Sekisui Diagnostics, LLC · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- L-Type HDL-C Reagent 1 — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- L-Type HDL-C Reagent 1 — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitalscientific
Sources (1)
- FDA UDI b6c83743-5c28-425b-bb67-e08ef4235728 32 fields · synced May 30, 2026