Duns Number:354019424
Device Description: ImmunoCAP Allergen Rc208, Tetanus toxoid
Catalog Number
14-5227-10
Brand Name
ImmunoCAP Allergen Rc208, Tetanus toxoid
Version/Model Number
14-5227-10
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
-
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
MVU
Product Code Name
Reagents, specific, analyte
Public Device Record Key
6d040616-2258-4eff-a7d7-40851090c098
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2020
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 | 225 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |