Duns Number:188354831
Device Description: 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. Substrate: 1 x15 ml vial.4. Washing solution (20x): 1x50mL vial.5. Dilution solution (10x): 1 x20mL vial.6. Extraction solution (2.5x): 2x50 mL vials.7. Calibrators: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml).8. Control 1: 1x1.0 mL vial.9. Control 2: 1x1.0 mL vial.
Catalog Number
-
Brand Name
QUANTA Lite® Calprotectin ELISA
Version/Model Number
704770
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
K191589
Product Code
NXO
Product Code Name
Calprotectin, Fecal
Public Device Record Key
98ec0e11-6cb3-421a-aed9-b65b016b64a3
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 31, 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 |