Primary Device ID | 00885502016007 |
NIH Device Record Key | 58134ad4-2420-47b6-b478-43503fccff97 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INFINITY™ High Control Solution |
Version Model Number | IGM-0024 |
Company DUNS | 828116728 |
Company Name | U.S. 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 | false |
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 | true |
Phone | 866-216-5308 |
jkupar@usdiagnostics.net | |
Phone | 866-216-5308 |
jkupar@usdiagnostics.net |
Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885502016007 [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 | 2018-10-25 |
Device Publish Date | 2018-09-24 |
00885502004004 - INFINITY™ Normal Control Solution | 2018-10-25 |
00885502004035 - EasyGluco™ Normal Control Solution | 2018-10-25 |
00885502015000 - INFINITY™ Low Control Solution | 2018-10-25 |
00885502015031 - EasyGluco™ Low Control Solution | 2018-10-25 |
00885502016007 - INFINITY™ High Control Solution | 2018-10-25 |
00885502016007 - INFINITY™ High Control Solution | 2018-10-25 |
00885502016038 - EasyGluco™ High Control Solution | 2018-10-25 |
00885502000006 - INFINITY™ Starter Kit | 2018-07-06 |
00885502000037 - EasyGluco™G2 Starter Kit | 2018-07-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INFINITY 98761246 not registered Live/Pending |
Zevex, Inc. 2024-09-20 |
INFINITY 98737979 not registered Live/Pending |
Marten Group, Inc. 2024-09-06 |
INFINITY 98643936 not registered Live/Pending |
Project Management Institute, Inc. 2024-07-11 |
INFINITY 98470220 not registered Live/Pending |
IBF IP, LLC 2024-03-27 |
INFINITY 98466286 not registered Live/Pending |
IBF IP, LLC 2024-03-25 |
INFINITY 98454204 not registered Live/Pending |
Tanks By Mail Inc 2024-03-18 |
INFINITY 98433629 not registered Live/Pending |
Infinity Generation Inc. 2024-03-05 |
INFINITY 98338571 not registered Live/Pending |
Careismatic Brands, LLC 2024-01-02 |
INFINITY 98293120 not registered Live/Pending |
PREFERRED COLLECTIONS INC. 2023-11-30 |
INFINITY 98275942 not registered Live/Pending |
Capital One Financial Corporation 2023-11-17 |
INFINITY 98242984 not registered Live/Pending |
IGH Holding Inc. 2023-10-27 |
INFINITY 98175956 not registered Live/Pending |
CellFE, Inc. 2023-09-12 |