Duns Number:215865786
Device Description: VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
Catalog Number
6801758
Brand Name
VITROS
Version/Model Number
6801758
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
K983690
Product Code
MOI
Product Code Name
SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
Public Device Record Key
af5a9715-9533-4fbc-9eec-3b49467c1f6c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 17 |