Duns Number:354019424
Device Description: Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method.
Catalog Number
10-9252-01
Brand Name
ImmunoCAP Total IgE Calibrators
Version/Model Number
10-9252-01
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
K133404
Product Code
DGC
Product Code Name
IGE, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
2aebbf7d-f791-48e6-9bea-0e4c1a498604
Public Version Date
April 03, 2019
Public Version Number
1
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 |