Duns Number:884513334
Device Description: U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3
Catalog Number
12000656
Brand Name
BioPlex 2200
Version/Model Number
4.3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GMQ
Product Code Name
ANTIGENS, NONTREPONEMAL, ALL
Public Device Record Key
ea8186ef-be70-4995-a5ae-4bb228d9b12e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 2017
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 |