FDA.reportPublic FDA data

VivaGuard Ino Control Solution

Primary DI
00840423500035
Brand
VivaGuard Ino Control Solution
Company
ABOUND Diagnostics, Inc.
Model
VGC01-373
Catalog number
VGC01-373
Device description
VivaGuard Ino Control Solution
Published
2025-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00840423500691PackageGS1480In Commercial Distribution
00840423500035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840423500691008404235006918404235006910840423500691
00840423500035008404235000358404235000350840423500035

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Regulatory Flags#

DUNS number
119217208
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840423500028VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
00840423500059VivaGuard Ino Smart Blood Glucose MeterVGM04-665VGM04-6652025-06-06
00840423500684VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
00840423500691VivaGuard Ino Control SolutionVGC01-373VGC01-3732025-06-06
00840423500707VivaGuard Ino Smart Blood Glucose MeterVGM04-665VGM04-6652025-06-06
00840423500004VivaGuard Ino Blood Glucose Meter VGM01-373VGM01-3732025-06-03
00840423500073VivaGuard Lancets (21G)VGL01-2U5VGL01-2U52025-04-11
00840423500080VivaGuard Lancets (23G)VGL01-2U4VGL01-2U42025-04-11
00840423500097VivaGuard Lancets (26G)VGL01-2U3VGL01-2U32025-04-11
00840423500134VivaGuard Lancing Device VGD01-381VGD01-3812025-04-11
00840423500141VivaGuard Safety Lancets (18G)VGL02-2U5VGL02-2U52025-04-11
00840423500165VivaGuard Safety Lancets (23G)VGL02-2U3VGL02-2U32025-04-11
00840423500172VivaGuard Safety Lancets (26G)VGL02-2U2VGL02-2U22025-04-11
00840423500189VivaGuard Safety Lancets (28G)VGL02-382VGL02-3822025-04-11
00840423500196VivaGuard Safety Lancets (30G)VGL02-2U1VGL02-2U12025-04-11
00840423500202CHOSEN Infrared Forehead ThermometerFTH800FTH8002025-04-11
00840423500363VivaGuard Lancets (33G)VGL01-2U1VGL01-2U12025-04-11
00840423500516VivaGuard Lancets (21G)VGL01-2U5VGL01-2U52025-04-11
00840423500509VivaGuard Lancets (23G)VGL01-2U4VGL01-2U42025-04-11
00840423500400VivaGuard Lancets (26G)VGL01-2U3VGL01-2U32025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21