Duns Number:502054265
Device Description: Procleix NAT Manager Software is designed to collect data from Procleix assays, instrument
Catalog Number
-
Brand Name
Procleix NAT Manager
Version/Model Number
1.2
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
BK160125
Product Code
PQQ
Product Code Name
Data Acquisition Software
Public Device Record Key
eb3b899b-9fa2-4788-80db-f2ea86d4b945
Public Version Date
November 16, 2020
Public Version Number
2
DI Record Publish Date
October 02, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |