Duns Number:312576506
Device Description: for 18 detections of human HLA-B27 antigen in the complement-dependent microlymphocytotoxi for 18 detections of human HLA-B27 antigen in the complement-dependent microlymphocytotoxicity test
Catalog Number
823110
Brand Name
Lymphotype HLA-B27 special
Version/Model Number
823110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2015
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
d661d32e-cf24-4509-8065-220d571d50de
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 01, 2015
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |