DEVICE: PD-L1 IHC 22C3 pharmDx (05700573003563)
Device Identifier (DI) Information
PD-L1 IHC 22C3 pharmDx
GE006
In Commercial Distribution
AGILENT TECHNOLOGIES, INC.
GE006
In Commercial Distribution
AGILENT TECHNOLOGIES, INC.
PD-L1 IHC 22C3 pharmDx
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 61934 | Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of programmed death-ligand 1 (PD-L1) in a clinical specimen, using an enzyme immunohistochemistry method.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P150013 | 000 |
| P150013 | 001 |
| P150013 | 002 |
| P150013 | 003 |
| P150013 | 004 |
| P150013 | 005 |
| P150013 | 006 |
| P150013 | 007 |
| P150013 | 008 |
| P150013 | 009 |
| P150013 | 010 |
| P150013 | 011 |
| P150013 | 012 |
| P150013 | 013 |
| P150013 | 014 |
| P150013 | 015 |
| P150013 | 016 |
| P150013 | 017 |
| P150013 | 018 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 60 tests |
Device Record Status
d825e5ae-5ef2-4c3f-ba89-f023558779bd
December 07, 2020
2
August 16, 2020
December 07, 2020
2
August 16, 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
[?]
No Customer Contact currently defined