Duns Number:884513334
Device Description: U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1
Catalog Number
6651665E
Brand Name
BioPlex 2200
Version/Model Number
SW4.1_1
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
OMI
Product Code Name
Multiplex flow immunoassay, t.Gondii, rubella and cmv.
Public Device Record Key
cc589741-55ac-48b8-907b-d8497c15a394
Public Version Date
January 23, 2020
Public Version Number
4
DI Record Publish Date
September 12, 2016
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 |