Duns Number:188354831
Device Description: 1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 125 mL, concentrated reagent.
Catalog Number
-
Brand Name
QUANTA Flash Calprotectin Extraction Buffer
Version/Model Number
701354
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
K170993
Product Code
NXO
Product Code Name
Calprotectin, Fecal
Public Device Record Key
919f4e2d-24c9-48cf-a684-0dd3930663c0
Public Version Date
November 06, 2020
Public Version Number
3
DI Record Publish Date
February 28, 2018
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 |