Duns Number:317134468
Device Description: The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determinati The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
Catalog Number
EIA-6133
Brand Name
Bordetella pertussis Toxin (PT) IgG ELISA
Version/Model Number
EIA-6133
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
GOX
Product Code Name
ANTIGEN, B. PERTUSSIS
Public Device Record Key
f0997625-e2b6-4773-8731-67bcc8248729
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
June 11, 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 |