NOVA Lite® ANA KSL Kit
GUDID 08426950514008
1. 25x 8-well ANA KSL Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 1.0mL ANA Homogeneous Pattern 4. 1x 1.0mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 10mL Mounting Medium 7. 1x 25 Coverslips
INOVA DIAGNOSTICS, INC.
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay| Primary Device ID | 08426950514008 |
| NIH Device Record Key | f11c28c4-8712-484c-baf1-92b67b21ed0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVA Lite® ANA KSL Kit |
| Version Model Number | 708380 |
| 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 | 08426950514008 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K901596
FDA Product Code
| DHN | Antinuclear Antibody, 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® ANA KSL Kit]
| 08426950514008 | 1. 25x 8-well ANA KSL Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 1.0mL ANA |
| 08426950506324 | 1. 10x 4-well ANA KSL Substrate Slides 2. 1x 7mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL ANA |
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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