Duns Number:064608573
Device Description: CMV IgG ADVIA Centaur - RGT - 100T
Catalog Number
10632820
Brand Name
ADVIA Centaur CMV IgG
Version/Model Number
10632820
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181213
Product Code
LFZ
Product Code Name
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
Public Device Record Key
055ba6d8-18a6-4254-892a-95ffa57fd676
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
February 10, 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 |