NOVA Lite®Rat Liver , Kidney, Stomach Kit
GUDID 08426950514176
1. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II Buffer (x40 conc) 9. 1 x 3mL Mounting Medium 10. 20 x Blotters 11. 10 x Coverslips 12. 1 x instruction leaflet
INOVA DIAGNOSTICS, INC.
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay| Primary Device ID | 08426950514176 |
| NIH Device Record Key | 83c5e2b9-5480-4417-8cdd-c3f0207efe44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVA Lite®Rat Liver , Kidney, Stomach Kit |
| Version Model Number | 704170 |
| 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 | 08426950514176 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K955431
FDA Product Code
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, 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 | 2021-06-08 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [NOVA Lite®Rat Liver , Kidney, Stomach Kit]
| 08426950545798 | 1. 25 x Rat liver, kidney, stomach slide (10-well) 2. 1 x 1mL ANA Homogeneous Pattern (predilute |
| 08426950514176 | 1. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted |
Trademark Results [NOVA Lite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVA LITE 77968845 3879164 Live/Registered |
Inova Diagnostics, Inc. 2010-03-25 |
 NOVA LITE 76038820 not registered Dead/Abandoned |
NAVAJO MANUFACTURING CO. 2000-05-02 |
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