FDA.reportPublic FDA data

THE EDGE Blood Lactate Test Strip (non-sterile)

Primary DI
04713648766547
Brand
THE EDGE Blood Lactate Test Strip (non-sterile)
Company
APEX BIOTECHNOLOGY CORP.
Model
The EDGE test strip
Device description
25s
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
CodeName
KHPAcid, Lactic, Enzymatic Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713648766547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713648766547047136487665474713648766547

GMDN Terms#

Term, Definition table
TermDefinition
Lactate monitoring system IVD, home-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657608092
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886338000048UASure II Blood Uric Acid Test Strips 25sS5640997S56409972021-12-27
00886338000031UASure II Blood Uric Acid Monitoring SystemS95046S950462021-12-27
04713648766493ApexBio SteriLance BLOOD LANCET (Sterile)lancet2020-05-15
00886338000062UASure II Blood Uric Acid Test Strips 25sS5640997S56409972021-12-27
00886338000055UASure II Uric Acid Control Solution L1S5800397S58003972021-12-27
04713648766530THE EDGE Blood Lactate Monitoring SystemThe EDGE meter2021-01-18
04713648766554THE EDGE Lactate Control SolutionThe EDGE control solution2021-01-18
04713648766462UASure Blood Uric Acid Monitoring Meter UASure Meter2020-05-11
04713648766479UASure Blood Uric Acid Test StripUASure I2020-05-11
04713648766486UASure uric acid control solutionUAsure control solution2020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05700699446572SP90Radiometer Medical ApSKHP2026-07-09
05700699447579SP90Radiometer Medical ApSKHP2026-07-09
05700699461056SC90Radiometer Medical ApSKHP2026-07-09
05700699461087SC90Radiometer Medical ApSKHP2026-07-09
05700699461094SC90Radiometer Medical ApSKHP2026-07-09
05700699461100SC90Radiometer Medical ApSKHP2026-07-09
05700699461605SC90Radiometer Medical ApSKHP2026-07-09
00816042014543FORAFORA CARE INC.KHP2025-05-06
80816042014549FORAFORA CARE INC.KHP2025-05-06
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSKHP2024-07-01
00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSKHP2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSKHP2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21