Home GUDID 04713648766530 THE EDGE Blood Lactate Monitoring System
Primary DI 04713648766530
Brand THE EDGE Blood Lactate Monitoring System
Company APEX BIOTECHNOLOGY CORP.
Model The EDGE meter
Device description KIT
Published 2021-01-18
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Single use true Product Codes# Code, Name table Code Name KHP Acid, Lactic, Enzymatic Method
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04713648766530 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04713648766530 04713648766530 4713648766530
GMDN Terms# Term, Definition table Term Definition Lactate monitoring system IVD, home-use A collection of devices including a dedicated, portable, electrically-powered instrument (self-testing meter) reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of lactate in a whole blood specimen.; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is typically used to monitor physical performance and conditioning in sport, and/or to support patient management.
Regulatory Flags# DUNS number 657608092 Device count 1 Premarket exempt true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00886338000048 UASure II Blood Uric Acid Test Strips 25s S5640997 S5640997 2021-12-27 00886338000031 UASure II Blood Uric Acid Monitoring System S95046 S95046 2021-12-27 04713648766493 ApexBio SteriLance BLOOD LANCET (Sterile) lancet 2020-05-15 00886338000062 UASure II Blood Uric Acid Test Strips 25s S5640997 S5640997 2021-12-27 00886338000055 UASure II Uric Acid Control Solution L1 S5800397 S5800397 2021-12-27 04713648766547 THE EDGE Blood Lactate Test Strip (non-sterile) The EDGE test strip 2021-01-18 04713648766554 THE EDGE Lactate Control Solution The EDGE control solution 2021-01-18 04713648766462 UASure Blood Uric Acid Monitoring Meter UASure Meter 2020-05-11 04713648766479 UASure Blood Uric Acid Test Strip UASure I 2020-05-11 04713648766486 UASure uric acid control solution UAsure control solution 2020-05-11
Other Devices Sharing Product Codes#