VivaGuard Ino VGC01-371

GUDID 00853483008076

VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)

Able Diagnostics Inc

Glucose IVD, kit, electrometry
Primary Device ID00853483008076
NIH Device Record Keyf88e728d-11a6-44ee-aefe-7added11e1fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivaGuard Ino
Version Model NumberVGC01
Catalog NumberVGC01-371
Company DUNS080952036
Company NameAble Diagnostics Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853483008076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

On-Brand Devices [VivaGuard Ino]

00853483008151VivaGuard Ino Blood Glucose Meter
00853483008052VivaGuard Ino Blood Glucose Meter Only Kit
00853483008014VivaGuard Ino Test strips 50s (25s/vial)
00853483008007VivaGuard Ino Blood Glucose Monitoring System
00853483008199VivaGuard Ino Control Solution (1 & 3)
00853483008182VivaGuard Ino Test strips 50s (50s/vial)
00853483008175VivaGuard Ino Control Solution 2 (1 bottle/kit)
00853483008076VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)

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