FDA.reportPublic FDA data

BIOCOACH Glucose Control Solution L1/L2

Primary DI
00850017460058
Brand
BIOCOACH Glucose Control Solution L1/L2
Company
AMVENTUREX, INC.
Model
S5800382
Catalog number
S5800382
Device description
Level 1 & 2
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017460058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017460058008500174600588500174600580850017460058

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117225590
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
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
00850017460034BIOCOACH Blood Glucose and Ketone Monitoring SystemS84102S841022021-12-28
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

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Primary DI, Brand, Company table
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00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
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00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
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00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
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