Duns Number:045361136
Device Description: For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antibodies in W
Catalog Number
6200-020
Brand Name
RELY Mono
Version/Model Number
6200-020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2022
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
KTN
Product Code Name
System, Test, Infectious Mononucleosis
Public Device Record Key
ea85140c-ce20-403c-b01a-edc2fc1b805a
Public Version Date
August 31, 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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |