FDA.reportPublic FDA data

VivaGuard Ino Blood Glucose Test Strips

Primary DI
00840423500684
Brand
VivaGuard Ino Blood Glucose Test Strips
Company
ABOUND Diagnostics, Inc.
Model
VGS01-378
Catalog number
VGS01-378
Device description
VivaGuard Ino Blood Glucose Test Strips
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
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840423500684PackageGS1300In Commercial Distribution
00840423500028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840423500684008404235006848404235006840840423500684
00840423500028008404235000288404235000280840423500028

GMDN Terms#

Term, Definition table
TermDefinition
Home-use blood glucose spot-check systemAn electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.

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
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
MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00383568100826CareLiving BGM101 Blood Glucose MeterCare Living Diagnostics Inc.CGA2024-08-07
00384840105003Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-11
00384840104006Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-10
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00383568100734CareLiving MM1100 Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2024-04-19
00383568100741CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2024-04-19
00383568100819CareLiving Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2023-11-15
00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
00381934755014eGLU, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-01
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
00381934748016Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-03-25
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.CGA2022-04-11
MHC18490502BluLinkMHC MEDICAL PRODUCTS, LLCCGA2021-05-12