QUANTA LITE®Calprotectin Extended Range
GUDID 08426950913337
1. Antibody coated plate 12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant. 2. Enzyme conjugate antibody (IgG) 1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use. 3. Substrate 1 vial containing 15 ml substrate reagent (TMB). Ready-to-use 4. Stop Solution 1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use 5. Washing solution (20x) 1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water. 6. Diluent solution (10x) 1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water. 7. Extraction solution (2.5x) 2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin. 8. Calibrators 6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use. 9. Control 1 1 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label. 10. Control 2 1 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
INOVA DIAGNOSTICS, INC.
Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 08426950913337 |
| NIH Device Record Key | 2cc97900-7e7a-4a0b-b06f-5de40a55c583 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA LITE®Calprotectin Extended Range |
| Version Model Number | 704860 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950913337 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191592
FDA Product Code
| NXO | Calprotectin, Fecal |
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 | 2020-08-21 |
| Device Publish Date | 2016-12-15 |
Devices Manufactured by INOVA DIAGNOSTICS, INC.
| 08426950454373 - QUANTA Lite® ANA ELISA | 2026-02-09 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL predilu |
| 08426950456193 - NOVA Lite® HEp-2 ANA Kit | 2026-02-09 1. 20x Hep- 2 ANA Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate |
| 08426950593461 - NOVA Lite® HEp-2 ANA Kit | 2026-02-09 1. 5 x 12-well HEp-2 Substrate Slides 2. 1 x 4mL FITC Anti-Human IgG Conjugate 3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Con |
| 08426950593577 - NOVA Lite® ANA Kit with DAPI | 2026-02-09 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI |
| 08426950594208 - NOVA Lite® HEp-2 External EB Kits | 2026-02-09 1. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Con |
| 08426950594857 - NOVA Lite® Auto AB Panel | 2026-02-09 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centr |
| 08426950595267 - NOVA Lite® HEp-2 External EB Kits | 2026-02-09 1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Contr |
| 08426950627692 - QUANTA Flash PR3 Reagents | 2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge |
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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