Tissue-Tek Genie® 8537-C010

GUDID 00615233002327

FITC anti-IgM Goat Polyclonal Antibody, 10 RTU capsules

SAKURA FINETEK U.S.A., INC.

Human immunoglobulin M (IgM) caprine conjugate antibody reagent IVD
Primary Device ID00615233002327
NIH Device Record Key42b24e29-afbb-4f42-a065-73cd1da3c7e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue-Tek Genie®
Version Model Number8537-C010
Catalog Number8537-C010
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 Kitfalse
Device Combination Productfalse
Single Usetrue
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
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
Phone+1(310)972-7800
EmailTS@sakuraus.com
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
GS100615233002327 [Primary]

FDA Product Code

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 Date2020-01-09
Device Publish Date2020-01-01

On-Brand Devices [Tissue-Tek Genie®]

00615233002686Wash Buffer
00615233002464High pH Antigen Retrieval Solution
00615233002457Citrate Antigen Retrieval Solution
00615233008152anti-Prostate Specific Antigen Rabbit Monoclonal Antibody [EP109], 10 RTU capsules
00615233008145anti-Prostate Specific Antigen Rabbit Monoclonal Antibody [EP109], 1 RTU cartridge
00615233008039Non-Immune Rabbit Ig Antibody, Negative Control, 1 RTU cartridge
00615233008022Non-Immune Mouse Ig Antibody, Negative Control, 1 RTU cartridge
00615233007544anti-CD19 Rabbit Monoclonal Antibody [EP169], 1 RTU cartridge
00615233007506anti-Lysozyme Rabbit Polyclonal Antibody, 1 RTU cartridge
00615233007421anti-CD19 Rabbit Monoclonal Antibody [EP169], 10 RTU capsules
00615233007384anti-Lysozyme Rabbit Polyclonal Antibody, 10 RTU capsules
00615233002860anti-Placental Alkaline Phosphatase Mouse Monoclonal Antibody [GM022], 1 RTU cartridge
00615233002853anti-Placental Alkaline Phosphatase Mouse Monoclonal Antibody [GM022], 10 RTU capsules
00615233002525Dewax Solution, RTU
00615233002488Antibody Diluent, 4/case
00615233002365Non-Immune Rabbit Ig Antibody, Negative Control, 10 RTU capsules
00615233002358Non-Immune Mouse Ig Antibody, Negative Control, 10 RTU capsules
00615233002341FITC anti-C3 Goat Polyclonal Antibody, 10 RTU capsules
00615233002334FITC anti-Fibrinogen Goat Polyclonal Antibody, 10 RTU capsules
00615233002327FITC anti-IgM Goat Polyclonal Antibody, 10 RTU capsules
00615233002310FITC anti-IgA Goat Polyclonal Antibody, 10 RTU capsules
00615233002303FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules
00615233002297anti-Podoplanin Mouse Monoclonal Antibody [D2-40], 10 RTU capsules
00615233002280anti-Podoplanin Mouse Monoclonal Antibody [D2-40], 1 RTU cartridge
00615233002273anti-PAX8 Rabbit Monoclonal Antibody [EP298], 1 RTU cartridge
00615233002266anti-PAX8 Rabbit Monoclonal Antibody [EP298], 10 RTU capsules
00615233002259anti-PAX5 Rabbit Monoclonal Antibody [EP156], 10 RTU capsules
00615233002242anti-PAX5 Rabbit Monoclonal Antibody [EP156], 1 RTU cartridge
00615233002211anti-p53 Mouse Monoclonal Antibody [BP53.12], 10 RTU capsules
00615233002204anti-p53 Mouse Monoclonal Antibody [BP53.12], 1 RTU cartridge
00615233002198anti-Ki67 Mouse Monoclonal Antibody [GM010], 1 RTU cartridge
00615233002181anti-Ki67 Mouse Monoclonal Antibody [GM010], 10 RTU capsules
00615233002174anti-Cyclin D1 Rabbit Monoclonal Antibody [EP12], 10 RTU capsules
00615233002167anti-Cyclin D1 Rabbit Monoclonal Antibody [EP12], 1 RTU cartridge
00615233002150anti-BCL6 Rabbit Monoclonal Antibody [EP278], 1 RTU cartridge
00615233002143anti-BCL6 Rabbit Monoclonal Antibody [EP278], 10 RTU capsules
00615233002136anti-BCL2 Rabbit Monoclonal Antibody [EP36], 10 RTU capsules
00615233002129anti-BCL2 Rabbit Monoclonal Antibody [EP36], 1 RTU cartridge
00615233002112anti-Synaptophysin Mouse Monoclonal Antibody [BS15], 1 RTU cartridge
00615233002105anti-Synaptophysin Mouse Monoclonal Antibody [BS15], 10 RTU capsules
00615233002099anti-Neuron Specific Enolase Rabbit Monoclonal Antibody [EP319], 10 RTU capsules
00615233002082anti-Neuron Specific Enolase Rabbit Monoclonal Antibody [EP319], 1 RTU cartridge
00615233002075anti-S100B Rabbit Monoclonal Antibody [EP32], 1 RTU cartridge
00615233002068anti-S100B Rabbit Monoclonal Antibody [EP32], 10 RTU capsules
00615233002051anti-Myeloperoxidase (MPO) Rabbit Monoclonal Antibody [EP151], 10 RTU capsules
00615233002044anti-Myeloperoxidase (MPO) Rabbit Monoclonal Antibody [EP151], 1 RTU cartridge
00615233002037anti-Lambda Light Chain Rabbit Polyclonal Antibody, 1 RTU cartridge
00615233002020anti-Lambda Light Chain Rabbit Polyclonal Antibody, 10 RTU capsules
00615233002013anti-Kappa Light Chain Rabbit Polyclonal Antibody, 10 RTU capsules
00615233002006anti-Kappa Light Chain Rabbit Polyclonal Antibody, 1 RTU cartridge

Trademark Results [Tissue-Tek Genie]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TISSUE-TEK GENIE
TISSUE-TEK GENIE
88367584 not registered Live/Pending
Sakura Finetek U.S.A., Inc.
2019-04-02
TISSUE-TEK GENIE
TISSUE-TEK GENIE
78452423 3551786 Live/Registered
Sakura Finetek U.S.A., Inc.
2004-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.