Duns Number:315786293
Device Description: ARCHITECT HIV Ag/Ab Combo Reagent Kit
Catalog Number
02P3635
Brand Name
ARCHITECT
Version/Model Number
2P36-35
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
BP090080,BP090080,BP090080,BP090080,BP090080
Product Code
MZF
Product Code Name
Test, hiv detection
Public Device Record Key
02d7834b-5fca-45d4-ba54-812319071dff
Public Version Date
May 10, 2021
Public Version Number
6
DI Record Publish Date
January 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 185 |
| 3 | A medical device with high risk that requires premarket approval | 13 |