Duns Number:064608573
Device Description: Atellica IM aHCV 200T Kit
Catalog Number
11207260
Brand Name
Atellica IM aHCV 200T
Version/Model Number
11207260
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P030056,P030056,P030056,P030056,P030056,P030056,P030056,P030056,P030056,P030056,P030056
Product Code
MZO
Product Code Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Public Device Record Key
46274c05-78f3-450a-ad57-c99691d1bff5
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
January 15, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |