FDA.reportPublic FDA data

Tissue-Tek® Paraform®

Primary DI
00615233010568
Brand
Tissue-Tek® Paraform®
Company
SAKURA FINETEK U.S.A., INC.
Model
7188
Catalog number
7188
Device description
PM Printer Adapter
Published
2022-11-08
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
IDZCassettes, Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233010568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233010568006152330105686152330105680615233010568

GMDN Terms#

Term, Definition table
TermDefinition
Immunoassay reagent vehicle tray IVD, reusableA removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.

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

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
10810050855904Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855911Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855928Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855935Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
20849832018302Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2026-04-30
10194484321663N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321670N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321687N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321694N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321700N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321717N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321755N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321212N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321229N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321359N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321366N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321373N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321380N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321397N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321403N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10849832001000Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001017Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001024Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001031Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001048Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001055Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832003097Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025822Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025839Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23