Duns Number:071245690
Device Description: Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)0.5 mL vial for approximately 50 tests
Catalog Number
6100
Brand Name
FITC TdT Reagent
Version/Model Number
6100A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
ff382136-36a8-4854-b353-ae6a0cc7eefd
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 2019
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 | 7 |