Duns Number:884513334
Device Description: U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
Catalog Number
665-3465A
Brand Name
BioPlex® 2200
Version/Model Number
SW4.2_v4
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
-
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
2027283b-ac39-4640-829c-7191868bbc1a
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
August 28, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |