Duns Number:119214195
Device Description: Immunological Fecal Occult Blood test
Catalog Number
-
Brand Name
hema-screen SPECIFIC
Version/Model Number
HSSPENV-20
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
fe6976b9-5e7e-433b-91be-bdea4c526d46
Public Version Date
April 08, 2022
Public Version Number
7
DI Record Publish Date
September 21, 2016
Package DI Number
20722355001108
Quantity per Package
10
Contains DI Package
10722355001101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 10
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |