NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
GUDID 08426951056538
1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide 2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI 3. 1 x 0.5mL dsDNA Positive 4. 1 x 0.5mL IFA System Negative Control 5. 2 x 25mL PBS II Concentrate (40x) 6. 1 x 7mL Mounting Medium 7. 1 x 20 Coverslips
INOVA DIAGNOSTICS, INC.
Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay| Primary Device ID | 08426951056538 |
| NIH Device Record Key | 84c4e428-3b3a-4c7e-a1ea-d2337316d780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit |
| Version Model Number | 708215 |
| 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 | 08426951056538 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192916
FDA Product Code
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase |
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 | 2021-04-08 |
| Device Publish Date | 2021-03-31 |
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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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