Duns Number:064608573
Device Description: ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE
Catalog Number
11219529
Brand Name
ADVIA 2120i with DAA Autosampler
Version/Model Number
11219529
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
K162977
Product Code
GKZ
Product Code Name
Counter, differential cell
Public Device Record Key
5d8b71cd-3c65-4a50-b0b3-b1a57372ee4f
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
May 20, 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 | 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 |