Duns Number:251005005
Device Description: Rapid Response FIT Mailers&Buffers&Cassettes - 36 Mailers + Buffers + Cassettes/Box
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
FOB-0MBC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110309,K110309
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
cc3cb2c1-a79f-4c2d-a484-a73227d45bc3
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 11, 2019
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 |