Identity
- Trade Name
- Uric Acid Test Strip FDA UDI
- Generic Name
- Uric acid monitoring system IVD, home-use FDA UDI
- Model / Reference
- PA 16,25strips/vial×2/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935740727013 FDA UDI
- FDA Product Code
- JHC FDA UDI
- GMDN Term
- Uric acid monitoring system IVD, home-use 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Uric acid monitoring system IVD, home-use
Uric Acid Test Strip by Urit Medical Electronic Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid monitoring system IVD, home-use.
- Blood Uric Acid Monitoring System — e-Linkcare Meditech Co., Ltd · Class I
- UASure Blood Uric Acid Test Strip — APEX BIOTECHNOLOGY CORP. · Class I
- Uric Acid Control solution(level 1) — e-Linkcare Meditech Co., Ltd · Class I
- FORA — FORA CARE INC. · Class I
- UASure Blood Uric Acid Monitoring Meter — APEX BIOTECHNOLOGY CORP. · Class I
- UASure II Blood Uric Acid Monitoring System — APEX BIOTECHNOLOGY CORP. · Class I
- Uric Acid Control solution(level 2) — e-Linkcare Meditech Co., Ltd · Class I
- FORA — FORA CARE INC. · 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
- Urit Medical Electronic Co., Ltd.
Sources (1)
- FDA UDI 388611b0-8aac-4b38-a4ef-a69fba2ee2e8 33 fields · synced May 30, 2026