Duns Number:064608573
Device Description: HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit
Catalog Number
1324827
Brand Name
ADVIA Centaur® Systems EHIV QC
Version/Model Number
10309010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2022
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
BP050030,BP050030,BP050030,BP050030,BP050030
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
3b1ab829-9918-4b5d-af40-dc2e3e9e1b4c
Public Version Date
August 05, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2014
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 |