V8 Storage Buffer Kit

GUDID M52518310

HELENA LABORATORIES CORPORATION

Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD
Primary Device IDM52518310
NIH Device Record Key060e0d83-5693-475e-a35d-3802b56ca274
Commercial Distribution StatusIn Commercial Distribution
Brand NameV8 Storage Buffer Kit
Version Model Number1831
Company DUNS079396131
Company NameHELENA LABORATORIES CORPORATION
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM52518310 [Primary]

FDA Product Code

CEFELECTROPHORETIC, PROTEIN FRACTIONATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-02
Device Publish Date2017-03-17

Devices Manufactured by HELENA LABORATORIES CORPORATION

M52518360 - V8 Urine Preparation Buffer2023-09-18
M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit2023-09-18
M52510680010 - SPIFE Touch, CSA 2015 (120V)2023-09-11
M52510690000 - SPIFE Touch (230V)2023-09-11
M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V)2023-09-11
M52510880020 - SPIFE 3000, "CE 2011" (120V)2023-09-11
M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V)2023-09-11
M52510890020 - SPIFE 3000, "CE 2011" (230V)2023-09-11

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