Duns Number:687769737
Device Description: The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomato The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.
Catalog Number
-
Brand Name
OcculTech Fecal Occult Blood Rapid Test
Version/Model Number
IM706-100M
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
-
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
dcb24a93-9888-4e62-abd5-cf074ac4f42d
Public Version Date
August 21, 2019
Public Version Number
1
DI Record Publish Date
August 13, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |