Identity
- Trade Name
- THE EDGE Blood Lactate Monitoring System FDA UDI
- Generic Name
- Lactate monitoring system IVD, home-use FDA UDI
- Device Name
- KIT FDA UDI
- Model / Reference
- The EDGE meter FDA UDI
- Description
- KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04713648766530 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Lactate monitoring system IVD, home-use
THE EDGE Blood Lactate Monitoring System by Apex Biotechnology Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate monitoring system IVD, home-use.
- Lactate Plus — NOVA BIOMEDICAL CORPORATION · Class I
- FORA — FORA CARE INC. · 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
- Apex Biotechnology Corp.
Sources (1)
- FDA UDI dc11fddc-dd0d-4a45-b23f-871995c0a594 33 fields · synced May 30, 2026