FDA.report

Tissue-Tek Genie®

Primary DI
00615233000705
Brand
Tissue-Tek Genie®
Company
SAKURA FINETEK U.S.A., INC.
Model
8259-C010
Catalog number
8259-C010
Device description
anti-CD20 Mouse Monoclonal Antibody [L26], 10 RTU capsules
Published
2020-01-01
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
true

Related Records

Product Codes

CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615233000705PrimaryGS10

GMDN Terms

TermDefinition
CD20 cell marker IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of CD20 cell marker in a clinical specimen, using an enzyme immunohistochemistry method.

Sterilization Methods

Method

Contacts

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

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