Duns Number:884513334
Device Description: Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1
Catalog Number
6652365A
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)
-
FDA Premarket Submission
-
Product Code
MST
Product Code Name
Antibodies, gliadin
Public Device Record Key
3aa5bb2e-8ee6-4536-9c8e-3e688b32e8c9
Public Version Date
February 07, 2020
Public Version Number
1
DI Record Publish Date
January 30, 2020
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 |