Identity
- Trade Name
- HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Model / Reference
- TD-4289 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850014861353 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
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
No
FDA UDI
Category: Uric acid IVD, reagent
HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) by Hearts Bio, Inc. — 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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- 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
- Hearts Bio, Inc.
Sources (1)
- FDA UDI fdcfedd6-5f8b-4562-815c-5e46c2446127 32 fields · synced Jun 8, 2026