Duns Number:884513334
Device Description: U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2
Catalog Number
12007240
Brand Name
BioPlex 2200
Version/Model Number
12007240
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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
ca827c6d-703a-4c80-9058-0bd274b294ca
Public Version Date
November 07, 2019
Public Version Number
3
DI Record Publish Date
February 05, 2018
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 |