Identity
- Trade Name
- Lactate Plus FDA UDI
- Generic Name
- Lactate monitoring system IVD, home-use FDA UDI
- Device Name
- Lactate Plus Blood Lactate Measuring Meter Kit FDA UDI
- Model / Reference
- Blood Lactate Measuring Meter FDA UDI
- Description
- Lactate Plus Blood Lactate Measuring Meter Kit FDA UDI
Identifiers
- Catalog Number
- 62624 FDA UDI
- Primary DI / UDI-DI
- 00385480626248 FDA UDI
- FDA Product Code
- KHP FDA UDI
- GMDN Term
- Lactate monitoring system IVD, home-use 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
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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lactate monitoring system IVD, home-use
Lactate Plus by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate monitoring system IVD, home-use.
- FORA — FORA CARE INC. · Class I
- THE EDGE Blood Lactate Monitoring System — APEX BIOTECHNOLOGY CORP. · Class I
- FORA — FORA CARE INC. · Class I
- THE EDGE Blood Lactate Test Strip (non-sterile) — APEX BIOTECHNOLOGY CORP. · 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
- Nova Biomedical Corporation
Sources (1)
- FDA UDI f0cf33c3-55c5-4bcb-94ca-4c040819fd49 35 fields · synced Jun 8, 2026