Primary Device ID | 00853483008076 |
NIH Device Record Key | f88e728d-11a6-44ee-aefe-7added11e1fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VivaGuard Ino |
Version Model Number | VGC01 |
Catalog Number | VGC01-371 |
Company DUNS | 080952036 |
Company Name | Able Diagnostics Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853483008076 [Primary] |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-11 |
Device Publish Date | 2021-02-03 |
00853483008151 | VivaGuard Ino Blood Glucose Meter |
00853483008052 | VivaGuard Ino Blood Glucose Meter Only Kit |
00853483008014 | VivaGuard Ino Test strips 50s (25s/vial) |
00853483008007 | VivaGuard Ino Blood Glucose Monitoring System |
00853483008199 | VivaGuard Ino Control Solution (1 & 3) |
00853483008182 | VivaGuard Ino Test strips 50s (50s/vial) |
00853483008175 | VivaGuard Ino Control Solution 2 (1 bottle/kit) |
00853483008076 | VivaGuard Ino Control Solution (L, M, H, 1 bottle/each) |