Identity
- Trade Name
- Blood Uric Acid Test Strips FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood FDA UDI
- Model / Reference
- SM411 FDA UDI
- Description
- Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16971404130949 FDA UDI
- FDA Product Code
- LFQ FDA UDI
- GMDN Term
- Uric acid IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1775 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: Uric acid IVD, reagent
Blood Uric Acid Test Strips by e-Linkcare Meditech Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Uric acid IVD, reagent.
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- Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
- URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
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 I | Pending data |
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Manufacturer
- Manufacturer
- e-Linkcare Meditech Co., Ltd
Sources (1)
- FDA UDI 823b0025-20f4-4815-a914-931287a9ca2a 33 fields · synced May 30, 2026