FDA.reportPublic FDA data

PD-L1 IHC 22C3 pharmDx

Primary DI
05700571107300
Brand
PD-L1 IHC 22C3 pharmDx
Company
AGILENT TECHNOLOGIES, INC.
Model
SK006
Device description
PD-L1 IHC 22C3 pharmDx
Published
2015-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 1Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150013000
P150013001
P150013002
P150013003
P150013004
P150013005
P150013006
P150013007
P150013008
P150013009
P150013010
P150013011
P150013012
P150013013
P150013014
P150013015
P150013016
P150013017
P150013018
P150013019
P150013020
P150013021
P150013022
P150013023
P150013024
P150013025
P150013026
P150013027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150013000PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013001PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013002PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013003PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013004PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013005PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013006PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013007PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013008PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013009PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013010PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013011PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013012PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013013PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013014PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013015PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013016PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013017PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013018PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013019PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013020PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013021PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013022PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013023PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013024PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013025PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013026PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS
P150013027PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571107300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571107300057005711073005700571107300

GMDN Terms#

Term, Definition table
TermDefinition
Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistryA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-805-566-6655dako.usregulatory@agilent.com
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags#

DUNS number
084963177
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700575016899PD-L1 Control SlidesT13912026-04-29
05700573001736PD-L1 Control SlidesT13912020-11-17
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1M36752026-01-21
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636M35692016-09-16
05700571107713DakoGC2062024-08-07
05700575005213MLH1 IHC pharmDx (Dako Omnis)GE0792025-08-27
05700575005220MSH2 IHC pharmDx (Dako Omnis)GE0852025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)GE0862025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)GE0872025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)GE1022025-08-27
05700571102022Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3M35012020-09-17
05700571102053Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10M35042020-09-17
05700571102190Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1M35392020-09-17
05700571102503Mono Mo A-Hu Tyrosinase Cl T311M36232020-09-17
05700571101933Mono Mo A-Thrombomodulin Cl 1009M06172020-09-17
05700571102039Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93M35022020-09-17
05700571101995Mono Mo A-Hu Muscle Actin Cl HHF35M06352020-09-17
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294M35682016-09-16
05700571102046Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042M35032020-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700571112755PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.PLS2020-11-17
05700573003563PD-L1 IHC 22C3 pharmDxAGILENT TECHNOLOGIES, INC.PLS2020-08-16
04015630972784VENTANA PD-L1 (SP263) AssayVentana Medical Systems, Inc.PLS2017-09-26
04015630967155VENTANA PDL1 SP142 ASSAYVentana Medical Systems, Inc.PLS2016-07-19
05700571108161PD-L1 IHC 28-8 pharmDxAGILENT TECHNOLOGIES, INC.PLS2015-10-13