Duns Number:201060071
Device Description: Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Typ Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Catalog Number
90-1019
Brand Name
INSTI HIV-1/HIV-2 Antibody Test
Version/Model Number
Single
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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
BP090032
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
0d992680-934d-42a9-b8da-151037ad045e
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
February 25, 2015
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. | 10 |