Duns Number:354019424
Device Description: Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal- Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal-17.5, Cal-100) to form a complete calibration curve for the ImmunoCAP Specific IgE method.
Catalog Number
10-9460-01
Brand Name
ImmunoCAP Specific IgE Calibrators 0-100
Version/Model Number
10-9460-01
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
K051218
Product Code
DHB
Product Code Name
System, test, radioallergosorbent (rast) immunological
Public Device Record Key
c08deffe-b237-4671-b56d-6ef22145980a
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 26, 2019
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 |