Duns Number:174517060
Device Description: ForSure iFOB test setContains:1 test device1 test reagent buffer1 sample collection set (m ForSure iFOB test setContains:1 test device1 test reagent buffer1 sample collection set (may or may not be included)
Catalog Number
-
Brand Name
ForSure iFOB Test Set
Version/Model Number
10210
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
K063693,K063693,K063693
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
0ba012ab-6548-446c-a207-ad90e596d811
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
30748349000022
Quantity per Package
50
Contains DI Package
00748349000021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |