Duns Number:243757049
Device Description: HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended HIV-1 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4.
Catalog Number
-
Brand Name
HIV-1 Antibody Test Controls
Version/Model Number
815311007590
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
BP000023,BP000023
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
fb58dc18-5648-407f-a6a5-dd6e35cfb848
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
January 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |