FDA.reportPublic FDA data

Tissue-Tek Genie®

Primary DI
00615233010810
Brand
Tissue-Tek Genie®
Company
SAKURA FINETEK U.S.A., INC.
Model
8346-M250
Catalog number
8346-M250
Device description
anti-Glypican-3 Mouse Monoclonal Antibody [1G12], RTU, cartridge containing 250 tests
Published
2026-10-23
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
false

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
00615233010810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233010810006152330108106152330108100615233010810

GMDN Terms#

Term, Definition table
TermDefinition
Glypican-3 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 glypican-3 in a clinical specimen.

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
00615233010803Tissue-Tek Genie®8345-M2508345-M2502026-10-23
00615233010834Tissue-Tek Genie®8345-C0108345-C0102026-10-23
00615233010841Tissue-Tek Genie®8346-C0108346-C0102026-10-23
00615233016409Tissue-Tek Genie®8387-C0108387-C0102026-10-23
00615233016416Tissue-Tek Genie®8387-M2508387-M2502026-10-23
00615233000491Tissue-Tek Genie®8242-C0108242-C0102020-01-01
00615233000507Tissue-Tek Genie®8242-M2508242-M2502020-01-01
00615233000637Tissue-Tek Genie®8253-M2508253-M2502020-01-01
00615233000644Tissue-Tek Genie®8253-C0108253-C0102020-01-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00615233010803Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2026-10-23
00615233010834Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2026-10-23
00615233010841Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2026-10-23
00615233016409Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2026-10-23
00615233016416Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2026-10-23
04065266563085SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563108SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563115SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563139SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563153SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
05055331340900BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
05055331340917BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
00810119671912Anti-HIF-1 alphaBIOGENEX LABORATORIESNJT2026-09-22
00810119672926Anti-Heat Shock Protein 27 (HSP 27)BIOGENEX LABORATORIESNJT2026-09-22
00810119673206Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119674463Anti-Beta-Tubulin IIBIOGENEX LABORATORIESNJT2026-09-22
00810119674531Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119675996Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119676016Anti-Beta-Tubulin IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679000Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679277Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00840542202629Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202636Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202650Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202667Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542203138Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203145Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203152Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203169Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203176Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22