Duns Number:114152184
Catalog Number
-
Brand Name
OraQuick In Home HIV Test, Pharmacy
Version/Model Number
1001-0528
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BP120001,BP120001,BP120001,BP120001,BP120001,BP120001,BP120001,BP120001,BP120001,BP120001
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
3b236dde-6c1e-45b0-96a1-47882b18fa37
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 01, 2017
Package DI Number
10608337001331
Quantity per Package
6
Contains DI Package
00608337001334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |