Duns Number:119214195
Device Description: A qualitative immunoassay for the detection of infectious mononucleosis heterophile antibo A qualitative immunoassay for the detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma
Catalog Number
-
Brand Name
Detector Mono
Version/Model Number
IDM-25
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
KTN
Product Code Name
SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
Public Device Record Key
2097c11a-3375-4dbf-b50b-07d15f77fd75
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
20722355001252
Quantity per Package
10
Contains DI Package
10722355001255
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 |