Identity
- Trade Name
- Vive Precision FDA UDI
- Generic Name
- Glucose IVD, reagent FDA UDI
- Device Name
- Blood Glucose Test Strips (100CT) FDA UDI
- Model / Reference
- DMD1082BLU100CT FDA UDI
- Description
- Blood Glucose Test Strips (100CT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113570778 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, reagent
Vive Precision by Vive Health Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, reagent.
- GLUC-PAP — Randox Laboratories, Ltd. · Class II
- GLUC-PAP — Randox Laboratories, Ltd. · Class II
- Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
- GoChek2 — Microtech Medical (Hangzhou) Co., Ltd. · Class II
- ENZYMATIC GLUCOSE — STERLING DIAGNOSTICS INC
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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vive Health Llc
Sources (1)
- FDA UDI 829903f0-804a-48e3-acdd-c484c6175696 33 fields · synced May 30, 2026