FDA.reportPublic FDA data

VivaGuard Ino

Primary DI
00853483008014
Brand
VivaGuard Ino
Company
Able Diagnostics Inc
Model
VGS01
Catalog number
VGS01-371
Device description
VivaGuard Ino Test strips 50s (25s/vial)
Published
2021-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160179000VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.2017-04-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853483008014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853483008014008534830080148534830080140853483008014

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080952036
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853483008076VivaGuard InoVGC01VGC01-3712021-02-03
00853483008175VivaGuard InoVGC01VGC01-3732021-02-03
00853483008182VivaGuard InoVGS01VGS01-3782021-02-03
00853483008199VivaGuard InoVGC01VGC01-3722021-02-03
00853483008236VivaGuard Ino SmartVGM04VGM04-6652021-02-03
00853483008243VivaGuard Ino SmartVGM042021-02-03
00853483008007VivaGuard InoVGM01VGM01-3712021-02-02
00853483008052VivaGuard InoVGM01VGM01-3732021-02-02
00853483008151VivaGuard Ino VGM012021-02-02
00853483008021VivaGuardVGL01VGL01-3822021-02-09
00853483008038VivaGuardVGD01VGD01-3812021-02-09
00853483008137VivaGuardVGL02VGL02-3822021-02-09
00853483008144VivaGuardVGL01VGL01-3832021-02-09
00853483008250VivaGuard® HA-650 Non-Contact Infrared Forehead ThermometerHA-650HA-6502020-12-08

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Primary DI, Brand, Company table
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00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
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00381934755014eGLU, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-20
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