Duns Number:884513334
Device Description: Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only
Catalog Number
6651965B
Brand Name
BioPlex 2200
Version/Model Number
SW4.1V1
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)
Yes
FDA Premarket Submission
-
Product Code
MID
Product Code Name
SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL
Public Device Record Key
dc72e4c8-92aa-4f88-8187-b17a112f30fe
Public Version Date
March 29, 2018
Public Version Number
2
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 |