Duns Number:940425333
Device Description: Positive control for use with ImmunoFA Toxoplasma IgM kit.
Catalog Number
1341
Brand Name
ImmunoFA Toxoplasma IgM Positive Control
Version/Model Number
800-1341
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
K803134
Product Code
GLZ
Product Code Name
Antigens, If, Toxoplasma Gondii
Public Device Record Key
859bd0dc-f8b1-423b-a615-693644c7f568
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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. | 32 |