FDA.reportPublic FDA data

Tissue-Tek Xpress®

Primary DI
10615233081510
Brand
Tissue-Tek Xpress®
Company
SAKURA FINETEK U.S.A., INC.
Model
7120
Catalog number
7120
Device description
Molecular Fixative
Published
2019-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDZFIXATIVE, ALCOHOL CONTAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615233081510PrimaryGS10
00615233081513Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061523308151010615233081510
00615233081513006152330815136152330815130615233081513

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue processing reagent kit IVDA collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
179135769
Device count
4
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
00673693181723EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-11-19
00673693228299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-09-04
00673693085465EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693556729EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693755146EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00860011780571Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00860011780588Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00380740129590AlinityAbbott GmbHLDZ2023-11-16
M84941010Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
M84941012Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
00810047420545N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420552N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420569N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420934N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420941N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420958N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420965N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021409Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085020181Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021423Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11