QUANTA Flash® DGP IgG Reagents
GUDID 08426950544166
1. 1 QUANTA Flash DGP IgG Reagent Cartridge
INOVA DIAGNOSTICS, INC.
Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay Gliadin antibody IVD, kit, chemiluminescent immunoassay| Primary Device ID | 08426950544166 |
| NIH Device Record Key | faf5a3be-02b7-46c7-886f-1d36057ebfbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA Flash® DGP IgG Reagents |
| Version Model Number | 701173 |
| Company DUNS | 188354831 |
| Company Name | INOVA 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950544166 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113863
FDA Product Code
| MST | Antibodies, Gliadin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-10-24 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [QUANTA Flash® DGP IgG Reagents ]
| 08426950627753 | 1 QUANTA Flash DGP IgG Reagent Cartridge |
| 08426950544166 | 1. 1 QUANTA Flash DGP IgG Reagent Cartridge |
Trademark Results [QUANTA Flash]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTA FLASH 77963733 4071260 Live/Registered |
Inova Diagnostics, Inc. 2010-03-19 |
 QUANTA FLASH 77729358 4067677 Live/Registered |
Inova Diagnostics, Inc. 2009-05-05 |
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