FDA.reportPublic FDA data

Tissue-Tek Genie®

Primary DI
00615233009920
Brand
Tissue-Tek Genie®
Company
SAKURA FINETEK U.S.A., INC.
Model
8281-C010
Catalog number
8281-C010
Device description
anti-CD99 Rabbit Monoclonal Antibody [EP8], 10 RTU capsules
Published
2021-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00615233009920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233009920006152330099206152330099200615233009920

GMDN Terms#

Term, Definition table
TermDefinition
CD99 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 CD99 cell marker in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810119672421Anti-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542207594Anti-CD2BIOGENEX LABORATORIESNJT2026-09-18
00840542207600Anti-CD2BIOGENEX LABORATORIESNJT2026-09-18
00840542207693Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542207709Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542207716Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542210181Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210198Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210204Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210211Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210228Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210235Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210242Anti-CD53BIOGENEX LABORATORIESNJT2026-09-18
00840542210259Anti-CD53BIOGENEX LABORATORIESNJT2026-09-18
00840542210266Anti-CD53BIOGENEX LABORATORIESNJT2026-09-18
00840542210426Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210433Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210457Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210464Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210945ANTI-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542210952ANTI-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542211201Anti-CD82BIOGENEX LABORATORIESNJT2026-09-18
00840542211218Anti-CD82BIOGENEX LABORATORIESNJT2026-09-18
00840542223280Anti-Inhibin AlphaBIOGENEX LABORATORIESNJT2026-09-18
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