Identity
- Trade Name
- Blood Uric Acid Monitoring System FDA UDI
- Generic Name
- Uric acid monitoring system IVD, home-use 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
- PM900C 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
- 06971404130928 FDA UDI
- FDA Product Code
- LFQ 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
No
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 monitoring system IVD, home-use
Blood Uric Acid Monitoring System by e-Linkcare Meditech Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FORA — FORA CARE INC. · Class I
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · Class I
- UASure Blood Uric Acid Monitoring Meter — APEX BIOTECHNOLOGY CORP. · Class I
- Uric Acid Test Strip — Urit Medical Electronic Co., Ltd. · Class I
- UASure II Blood Uric Acid Monitoring System — APEX BIOTECHNOLOGY CORP. · 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
- e-Linkcare Meditech Co., Ltd
Sources (1)
- FDA UDI 77dd8ece-d8cd-42f2-bb49-9ceff870f0f4 33 fields · synced May 30, 2026