Identity
- Trade Name
- HeartsCare LACTATE TEST STRIPS (25PCS/BOX) FDA UDI
- Generic Name
- Lactate IVD, reagent FDA UDI
- Model / Reference
- TD-4289 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850014861537 FDA UDI
- FDA Product Code
- KHP FDA UDI
- GMDN Term
- Lactate IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1450 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: Lactate IVD, reagent
HeartsCare LACTATE TEST STRIPS (25PCS/BOX) by Hearts Bio, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f54072ce-525e-40b3-bfc9-26d6c77049f4 32 fields · synced Jun 8, 2026