FDA.reportPublic FDA data

Tissue-Tek Genie®

Primary DI
00615233000828
Brand
Tissue-Tek Genie®
Company
SAKURA FINETEK U.S.A., INC.
Model
8267-C010
Catalog number
8267-C010
Device description
anti-CD117 (c-kit) Rabbit Monoclonal Antibody [EP10], 10 RTU capsules
Published
2020-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233000828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233000828006152330008286152330008280615233000828

GMDN Terms#

Term, Definition table
TermDefinition
CD117 (c-kit) cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD117 (c-kit) cell marker in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags#

DUNS number
179135769
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00615233011435Tissue-Tek Genie®8358-C0108358-C0102025-12-26
00615233011442Tissue-Tek Genie®8358-M2508358-M2502025-12-26
00615233013996Tissue-Tek Genie®8359-M2508359-M2502025-12-26
00615233014009Tissue-Tek Genie®8359-C0108359-C0102025-12-26
00615233014474Tissue-Tek Genie®8288-M2508288-M2502025-12-26
00615233014481Tissue-Tek Genie®8288-C0108288-C0102025-12-26
00615233014559Tissue-Tek Genie®8379-C0108379-C0102025-12-26
00615233014566Tissue-Tek Genie®8379-M2508379-M2502025-12-26
00615233011411Tissue-Tek Genie®8357-M2508357-M2502025-06-24
00615233011428Tissue-Tek Genie®8357-C0108357-C0102025-06-24
00615233013965Tissue-Tek Genie®8364-C0108364-C0102025-06-24
00615233013972Tissue-Tek Genie®8364-M2508364-M2502025-06-24
00615233011008Tissue-Tek Prisma®49002024-10-11
04946433600584Tissue-VIP® 6 AI60422024-10-11
00615233010605Tissue-Tek Genie®8386-C0108386-C0102024-05-17
00615233010612Tissue-Tek Genie®8386-M2508386-M2502024-05-17
00615233011312Tissue-Tek Genie®8337-M2508337-M2502024-05-17
00615233011350Tissue-Tek Genie®8356-C0108356-C0102024-05-17
00615233011367Tissue-Tek Genie®8356-M2508356-M2502024-05-17
00615233011329Tissue-Tek Genie®8337-C0108337-C0102024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336182765VENTANA pan-TRK (EPR17341) AssayVentana Medical Systems, Inc.NJT2026-03-16
00847627042637Pan TRK [RM423]BIOCARE MEDICAL LLCNJT2026-02-19
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00847627042279CK7BIOCARE MEDICAL LLCNJT2026-01-29
00847627042033DesminBIOCARE MEDICAL LLCNJT2026-01-13
00847627042835CD19BIOCARE MEDICAL LLCNJT2026-01-13
00847627041937Myeloperoxidase (P)BIOCARE MEDICAL LLCNJT2026-01-06
00847627042514VimentinBIOCARE MEDICAL LLCNJT2026-01-06
00615233011435Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233011442Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233013996Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014009Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014474Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014481Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014559Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014566Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00847627042019CD43BIOCARE MEDICAL LLCNJT2025-12-16
00847627042118Cytokeratin 18 (CK18)BIOCARE MEDICAL LLCNJT2025-12-16
00847627042491CD79aBIOCARE MEDICAL LLCNJT2025-12-16
00847627042576Cytokeratin [AE1] LMWBIOCARE MEDICAL LLCNJT2025-12-16
00847627042897CD103 (RM)BIOCARE MEDICAL LLCNJT2025-12-16
04015630971176Bluing ReagentVentana Medical Systems, Inc.NJT2025-12-15
04015630971299Amplification KitVentana Medical Systems, Inc.NJT2025-12-15
04015630972128CONFIRM anti-ALK1 (ALK01) Primary AntibodyVentana Medical Systems, Inc.NJT2025-12-15
07613336158357VENTANA Red ISH DIG Detection KitVentana Medical Systems, Inc.NJT2025-12-15
07613336158418VENTANA Silver ISH DNP Detection KitVentana Medical Systems, Inc.NJT2025-12-15
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNJT2025-11-25
00847627042132CD7BIOCARE MEDICAL LLCNJT2025-11-25
00847627042965Pan Melanoma Cocktail-2BIOCARE MEDICAL LLCNJT2025-11-17
00847627039095Desmoglein 3BIOCARE MEDICAL LLCNJT2025-09-19