Duns Number:878263359
Device Description: Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG)
Catalog Number
6L18-67
Brand Name
RealTime
Version/Model Number
6L18-67
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
BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002
Product Code
MZF
Product Code Name
Test, hiv detection
Public Device Record Key
6d0ce359-68b1-40f6-ae59-28b3e3b36c12
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 01, 2016
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |