DEVICE: VENTANA PD-L1 (SP263) Assay (04015630972784)
Device Identifier (DI) Information
VENTANA PD-L1 (SP263) Assay
50 test
In Commercial Distribution
07208162001
Ventana Medical Systems, Inc.
50 test
In Commercial Distribution
07208162001
Ventana Medical Systems, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
62046 | Programmed death-ligand 1 (PD-L1) 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 programmed death-ligand 1 (PD-L1), also known as CD274, in a clinical specimen.
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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 [?] |
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P160046 | 000 |
P160046 | 010 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dd70dc67-19c7-4989-a5b8-1606a046d44a
November 10, 2021
5
September 26, 2017
November 10, 2021
5
September 26, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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