Identity
- Trade Name
- UASure II Blood Uric Acid Monitoring System FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Complete Kit FDA UDI
- Model / Reference
- S95046 FDA UDI
- Description
- Complete Kit FDA UDI
Identifiers
- Catalog Number
- S95046 FDA UDI
- Primary DI / UDI-DI
- 00886338000031 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Uric acid IVD, reagentUric acid monitoring system IVD, home-use
UASure II Blood Uric Acid Monitoring System by Apex Biotechnology Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid monitoring system IVD, home-use.
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · Class I
- Blood Uric Acid Monitoring System — e-Linkcare Meditech Co., Ltd · Class I
- Uric Acid Control solution(level 1) — e-Linkcare Meditech Co., Ltd · Class I
- FORA — FORA CARE INC. · Class I
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · Class I
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · Class I
- Uric Acid Control solution(level 2) — e-Linkcare Meditech Co., Ltd · Class I
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (1)
- FDA UDI 5fe440e6-f316-4a53-9054-9054c3c1946d 34 fields · synced May 30, 2026