Tissue-Tek Genie® DUO 8837-K250

GUDID 00615233007636

Mouse-DAB/Rabbit-AP Red Dual Detection Kit

SAKURA FINETEK U.S.A., INC.

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Primary Device ID00615233007636
NIH Device Record Keyea7cc244-f664-4140-9fae-a7a1c872ccb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue-Tek Genie® DUO
Version Model Number8837-K250
Catalog Number8837-K250
Company DUNS179135769
Company NameSAKURA FINETEK U.S.A., INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100615233007636 [Primary]
GS100615233007636 [Primary]
GS100615233007636 [Primary]

FDA Product Code

NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Tissue-Tek Genie® DUO]

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00615233007971anti-Melan A [EP43] / Ki67 [GM010] Antibody Cocktail, 1 RTU cartridge
00615233007964anti-Melan A [EP43] / Ki67 [GM010] Antibody Cocktail, 10 RTU capsules
00516233007636Mouse-DAB/Rabbit-AP Red Dual Detection Kit
00615233007636Mouse-DAB/Rabbit-AP Red Dual Detection Kit

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