Duns Number:606034197
Catalog Number
888623
Brand Name
LIFECODES MATCH IT!™ DNA Software v1.3
Version/Model Number
888623
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK190439
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
e8791124-c149-454d-84e7-5320ade4bce4
Public Version Date
March 05, 2020
Public Version Number
1
DI Record Publish Date
February 26, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 54 |
U | Unclassified | 36 |