Duns Number:797393659
Device Description: Accutest iFOBT - Specimen Collection KitContains: 25 Patient specimen mailers collection k Accutest iFOBT - Specimen Collection KitContains: 25 Patient specimen mailers collection kit
Catalog Number
-
Brand Name
Accutest iFOBT - Specimen Collection Kit
Version/Model Number
CS620
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
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
60286de9-2451-48c0-9fc6-21b6c337ec90
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 23, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |