Duns Number:188354831
Device Description: 1. Antibody coated plate12x8 wells coated with antibody against calprotectin. Plastic seal 1. Antibody coated plate12x8 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. Substrate1 vial containing 15 ml substrate reagent (TMB). Ready-to-use4. Stop Solution1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use5. 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. Calibrators6 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 11 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 21 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
Catalog Number
-
Brand Name
QUANTA LITE®Calprotectin Extended Range
Version/Model Number
704860
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191592
Product Code
NXO
Product Code Name
Calprotectin, Fecal
Public Device Record Key
2cc97900-7e7a-4a0b-b06f-5de40a55c583
Public Version Date
August 21, 2020
Public Version Number
4
DI Record Publish Date
December 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |