NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents
GUDID 08426950596455
1. 8 prepunched NOVA Gel titering “T” plates 2. 2 0.4mL Jo-1 antigen, lyophilized 3. 1 1.4mL Jo-1 Control
INOVA DIAGNOSTICS, INC.
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion| Primary Device ID | 08426950596455 |
| NIH Device Record Key | 445c7b06-ad37-4c41-afb7-0b5e5f97239e |
| Commercial Distribution Discontinuation | 2018-05-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents |
| Version Model Number | 708495 |
| 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 | |
| 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 |
| 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 | 08426950596455 [Primary] |
FDA Product Code
| LLL | Extractable Antinuclear Antibody, Antigen And Control |
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 | 2022-03-08 |
| Device Publish Date | 2016-08-31 |
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| 08430793040761 - Aptiva® APS IgG Calibrators | 2024-03-19 1.Aptiva APS IgG Calibrator 1 (2x0.3mL) 2. Aptiva APS IgG Calibrator 2 (2x0.3mL) 3. Aptiva APS IgG Calibrator 3 (2x0.3mL) |
Trademark Results [NOVA Gel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVA GEL 87596838 not registered Dead/Abandoned |
Nguyen, John 2017-09-05 |
 NOVA GEL 77968875 3879165 Dead/Cancelled |
Inova Diagnostics, Inc. 2010-03-25 |
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