FDA.reportPublic FDA data

BIOCOACH Blood Glucose and Ketone Monitoring System

Primary DI
00850017460034
Brand
BIOCOACH Blood Glucose and Ketone Monitoring System
Company
AMVENTUREX, INC.
Model
S84102
Catalog number
S84102
Device description
Complete Kit
Published
2021-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201880000MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.2021-10-15NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017460034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017460034008500174600348500174600340850017460034

GMDN Terms#

Term, Definition table
TermDefinition
Ketone (acetoacetate) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen, using a spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117225590
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017460089BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)S5640934S56409342023-05-31
00850017460287BIOCOACH Blood Glucose Test Strips 50 Pack (Foil)S5640936S56409362023-05-31
00850017460027BIOCOACH Blood Glucose Test Strips 50sS5640989S56409892021-12-28
00850017460058BIOCOACH Glucose Control Solution L1/L2S5800382S58003822021-12-28
00850017460065BIOCOACH Blood Glucose Test Strips 25sS5640988S56409882021-12-28
00860060002310KETOCOACH BLOOD KETONE METERs110062019-12-30
00860060002327KETOCOACH 50 BLOOD KETONE TEST STRIPSS56407912019-12-30
00860060002334KETOCOACH CONTROL SOLUTION Level 2S58003352019-12-30
00860060002341KETOCOACH METER ONLYS110072019-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
16971404131199Blood Ketone Test Stripse-Linkcare Meditech Co., LtdJIN2021-12-17
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01