FDA.reportPublic FDA data

PD-L1 IHC 28-8 pharmDx

Primary DI
05700571108161
Brand
PD-L1 IHC 28-8 pharmDx
Company
AGILENT TECHNOLOGIES, INC.
Model
SK005
Device description
PD-L1 IHC 28-8 pharmDx
Published
2015-10-13
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571108161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571108161057005711081615700571108161

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
05700571107300PD-L1 IHC 22C3 pharmDxAGILENT TECHNOLOGIES, INC.PLS2015-10-05