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THE EDGE Blood Lactate Test Strip (non-sterile)

FDA UDIEUDAMED

Class I (US FDA UDI)

by Apex Biotechnology Corp.

Identity

Trade Name
THE EDGE Blood Lactate Test Strip (non-sterile) FDA UDI
Generic Name
Lactate monitoring system IVD, home-use FDA UDI
Device Name
25s FDA UDI
Model / Reference
The EDGE test strip FDA UDI
Description
25s FDA UDI

Identifiers

Primary DI / UDI-DI
04713648766547 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Lactate monitoring system IVD, home-use

THE EDGE Blood Lactate Test Strip (non-sterile) by Apex Biotechnology Corp. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Lactate monitoring system IVD, home-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apex Biotechnology Corp.

Sources (2)

  • FDA UDI ff5cde81-d564-4e35-964e-28ea04ba014a 33 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026