DEVICE: Tissue-Tek Genie® (00615233008275)
Device Identifier (DI) Information
Tissue-Tek Genie®
8234-C010
In Commercial Distribution
8234-C010
SAKURA FINETEK U.S.A., INC.
8234-C010
In Commercial Distribution
8234-C010
SAKURA FINETEK U.S.A., INC.
anti-Granzyme B Rabbit Monoclonal Antibody [EP230], 10 RTU caspules
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57250 | Granzyme B IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of granzyme B in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fccb29c0-fbe1-4b33-82dd-ac3fbe5d66e8
March 11, 2020
1
March 03, 2020
March 11, 2020
1
March 03, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(310)972-7800
TS@sakuraus.com
TS@sakuraus.com