Identity
- Trade Name
- ENVOY 500 GGT REAGENT KIT FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 55352 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700800163 FDA UDI
- GMDN Term
- Gamma-glutamyltransferase (GGT) 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Envoy 500 Ggt Reagent Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry.
- Dimension® Flex® reagent cartridge GGT — Siemens Healthcare Diagnostics · Class I
- Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz — Roche Diagnostics Corp. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209 — Carolina Liquid Chemistries Corp. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz — Roche Diagnostics Corp. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209 — Carolina Liquid Chemistries Corp. · 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 0ad4c0cb-3639-4398-940f-b5f00e9f6609 32 fields · synced Jun 7, 2026