FDA.reportPublic FDA data

PD-L1 Control Slides

Primary DI
05700571112755
Brand
PD-L1 Control Slides
Company
AGILENT TECHNOLOGIES, INC.
Model
T1391
Device description
PD-L1 Control Slides
Published
2020-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIRCells, Animal And Human, Cultured
PLSImmunohistochemistry assay, antibody, programmed death-ligand 1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1
PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 1Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150013000PD-L1 IHC 22C3 PHARMDXAgilent Technologies, Inc.2015-10-02PLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700573001736PrimaryGS10
05700571112755Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700573001736057005730017365700573001736
05700571112755057005711127555700571112755

GMDN Terms#

Term, Definition table
TermDefinition
Programmed death-ligand 1 (PD-L1) IVD, controlA material which is used to verify the performance of an assay 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.

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
+1-877-424-4536contact_us@agilent.com

Regulatory Flags#

DUNS number
084963177
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05700575016899PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2026-04-29
04015630972524HER2 Dual ISH 3-in-1 Xenograft SlidesVentana Medical Systems, Inc.KIR2021-02-03
04015630971091HER2 3-in-1 Xenograft Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
04015630971909HPV FAMILY 6 SYSTEM CONTROL SLIDES [B]Ventana Medical Systems, Inc.KIR2021-01-29
04015630971961HPV 3 in 1 System Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
05700573001736PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
30014613339571Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-10-02
30014613339564Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-09-25
05700573003563PD-L1 IHC 22C3 pharmDxAGILENT TECHNOLOGIES, INC.PLS2020-08-16
30014613339274Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
30014613339281Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
B7829500A07TdT Control Cell SuspensionSupertechs, Inc.KIR2019-10-08
30014613331377Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331384Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331391Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331407Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331414Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331421Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331438Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331445Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331698Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331704Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331711Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331728Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331735Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331742Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331759Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331766Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331773Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331780Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21