FDA.reportPublic FDA data

VivaGuard Ino Control Solution

Primary DI
00840423500691
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
Rx
false
OTC
true
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119217208
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840423500028VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
00840423500035VivaGuard Ino Control SolutionVGC01-373VGC01-3732025-06-06
00840423500059VivaGuard Ino Smart Blood Glucose MeterVGM04-665VGM04-6652025-06-06
00840423500684VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
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