Duns Number:251005005
Device Description: Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces.
Catalog Number
FOB-9C36
Brand Name
Rapid Response
Version/Model Number
FOB-9C36
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061065,K110309,K061065,K110309
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
a8415781-8d4f-4206-9c22-215a6015bd3b
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
October 25, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |