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
57477a05-145e-4493-90c1-201d15498b2a
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 |