Duns Number:050579217
Catalog Number
PRD-03566
Brand Name
APTIMA
Version/Model Number
HIV VIRAL ASSAY CAL, APTIMA, US IVD
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
BP150318
Product Code
MZF
Product Code Name
Test, hiv detection
Public Device Record Key
752878c5-a657-4d48-8bf9-a70a2e891d2f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 18, 2017
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 | 130 |
2 | A medical device with a moderate to high risk that requires special controls. | 311 |
3 | A medical device with high risk that requires premarket approval | 96 |