EasyGluco™ Normal Control Solution IGMNORM
GUDID 00885502004035
U.S. DIAGNOSTICS INC.
Glucose IVD, control| Primary Device ID | 00885502004035 |
| NIH Device Record Key | d1888cf2-a112-42db-a21a-8deac41394a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EasyGluco™ Normal Control Solution |
| Version Model Number | IGM-0008 |
| Catalog Number | IGMNORM |
| 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 |
Customer Support Contacts
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net | |
| Phone | 866-216-5308 |
| jkupar@usdiagnostics.net |
Operating and Storage Conditions
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885502004035 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061431
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
Devices Manufactured by U.S. DIAGNOSTICS INC.
| 10885502002007 - INFINITY™ Test Strips | 2024-11-11 |
| 00885502002031 - EasyGluco™G2 Test Strips | 2024-11-11 |
| 10885502002045 - Control™ Test Strips | 2024-11-11 |
| 00885502004004 - INFINITY™ Normal Control Solution | 2018-10-25 |
| 00885502004035 - EasyGluco™ 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 |
Trademark Results [EasyGluco]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EASYGLUCO 78535487 3050072 Live/Registered |
US DIAGNOSTICS, INC. 2004-12-20 |
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