QUANTA Lite® Chromatin ELISA
GUDID 08426950506355
1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Chromatin ELISA Low Positive 4. 1x 1.2mL prediluted Chromatin ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
Nucleosomal antibody IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 08426950506355 |
| NIH Device Record Key | 0cd7f99c-a313-4c59-b595-2e4e419db0d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA Lite® Chromatin ELISA |
| Version Model Number | 708710 |
| 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 | |
| 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 |
| 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 | 08426950506355 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982603
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 | 2024-11-07 |
| Device Publish Date | 2016-08-31 |
Devices Manufactured by INOVA DIAGNOSTICS, INC.
| 08426950506355 - QUANTA Lite® Chromatin ELISA | 2024-11-071. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Chromatin ELISA Low Positive 4. 1x 1.2mL prediluted Chromatin ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid |
| 08426950506355 - QUANTA Lite® Chromatin ELISA | 2024-11-07 1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL p |
| 00195126000871 - Aptiva® System Cleaning Solution Kit | 2024-03-26 The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module |
| 00195126000741 - Aptiva® Instrument System Cuvettes | 2024-03-19 The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument Syste |
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| 08426950865131 - QUANTA-Lyser® 3000 /IFA | 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie |
| 08426951307227 - Aptiva® Multi-Analyte Instrument | 2024-03-19 Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The sy |
| 08430793040716 - Aptiva® APS IgG Reagent | 2024-03-19 1. Aptiva APS IgG Reagent Cartridge -APS IgG Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgG(1x17mL) -Rehydration Buffer ( |
Trademark Results [QUANTA Lite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTA LITE 75085406 2115253 Live/Registered |
INOVA DIAGNOSTICS, INC. 1996-04-01 |
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