FDA.reportPublic FDA data

Dako

Primary DI
05700571104057
Brand
Dako
Company
AGILENT TECHNOLOGIES, INC.
Model
K1907
Device description
c-Kit pharmDx for Autostainer
Published
2016-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKFImmunohistochemistry Antibody Assay, C-Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKFImmunohistochemistry Antibody Assay, C-KitHematology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040011000C-KIT PHARMDXDako North America, Inc.2005-06-27NKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571104057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571104057057005711040575700571104057

GMDN Terms#

Term, Definition table
TermDefinition
CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of CD117 (c-kit) cell marker 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

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
00840493410296RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKF2026-02-02
05700571104040DakoAGILENT TECHNOLOGIES, INC.NKF2016-11-11
04015630971916PATHWAY Anti-c-KIT (9.7) Primary AntibodyVentana Medical Systems, Inc.NKF2014-09-11