Duns Number:317134468
Device Description: Anti-Lactoferrin ELISA is a test system for the quantitative measurement of IgG class auto
Catalog Number
EIA-3602
Brand Name
Anti-Lactoferrin ELISA
Version/Model Number
EIA-3602
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
DEG
Product Code Name
LACTOFERRIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
2f211124-133b-4158-b23a-2d6f4cf611fd
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
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 | 84 |
2 | A medical device with a moderate to high risk that requires special controls. | 27 |