DEVICE: PD-L1 IHC 22C3 pharmDx (05700571107300)

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Device Record History
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Device Identifier (DI) Information
PD-L1 IHC 22C3 pharmDx
SK006
In Commercial Distribution

AGILENT TECHNOLOGIES, INC.
05700571107300
GS1

1
084963177 *Terms of Use
PD-L1 IHC 22C3 pharmDx
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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
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FDA Product Code

[?]
Product Code Product Code Name
PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
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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
P150013 019
P150013 020
P150013 021
P150013 022
P150013 023
P150013 024
P150013 025
P150013 026
P150013 027
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50 test
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Device Record Status
6f248621-1126-4c13-8df1-b1707064c6b9
November 10, 2023
10
October 05, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1-800-227-9770
Global.RA@agilent.com
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