Duns Number:176458115
Device Description: Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples.
Catalog Number
-
Brand Name
COMPLIANCE GOLD iFOB SIMPLE
Version/Model Number
74030
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
-
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
e7286ae6-ee15-41de-bd6a-23e844a24221
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 27, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |