FDA.reportPublic FDA data

Tissue-Tek Genie®

Primary DI
00615233000507
Brand
Tissue-Tek Genie®
Company
SAKURA FINETEK U.S.A., INC.
Model
8242-M250
Catalog number
8242-M250
Device description
anti-GATA3 Rabbit Monoclonal Antibody [EP368], 1 cartridge
Published
2020-01-01
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
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
00615233000507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233000507006152330005076152330005070615233000507

GMDN Terms#

Term, Definition table
TermDefinition
GATA protein transcription factor 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 a GATA protein transcription factor (e.g., GATA1, GATA3) 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615233000491Tissue-Tek Genie®8242-C0108242-C0102020-01-01
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
00615233013972Tissue-Tek Genie®8364-M2508364-M2502025-06-24
00615233010629Genemed®60-0226-1560-0226-152023-10-16
00615233003577Genemed®61-015461-01542023-07-05
00615233006066Genemed®60-0154-760-0154-72023-07-05
00615233008183Genemed®60-0221-1560-0221-152020-07-10
00615233011008Tissue-Tek Prisma®49002024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841683151340Arginase-1 SP156 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151388Ep-CAM MOC31 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151395GATA3 L50-823 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151401Glypican-3 1G12 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151425IgG4 MRQ-44 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151432Mammaglobin 31A5 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151449Microphthalmia Transcription Factor (MiTF) C5/D5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151463Napsin A MRQ-60 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151470p120 Catenin MRQ-5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151487PAX8 MRQ-50 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151494PHH3 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151517Podoplanin D2-40 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151524Renal Cell Carcinoma PN-15 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151531S100 Protein 4C4.9 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151548SOX-10 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151555SOX-11 MRQ-58 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151562SOX-2 SP76 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151579C4d SP91 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
04065271108967Claudin-4 (EP417) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-04
00846405016808Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016839Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016846Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020102Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020126Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020133Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09