Duns Number:119214195
Device Description: A rapid latex agglutination slide test for the detection of heterophile antibodies associa A rapid latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis
Catalog Number
-
Brand Name
Detector Lex-IM
Version/Model Number
IMLX-100
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)
Yes
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
K972457,K972457
Product Code
KTN
Product Code Name
SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
Public Device Record Key
057803e1-2c3c-4f2b-8467-36e2eb10a27d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |