H-Pette II (No Blade, Metal Canula) (1000 pieces)

GUDID M52536150

HELENA LABORATORIES CORPORATION

Blood specimen transfer spike IVD
Primary Device IDM52536150
NIH Device Record Key282bf1e9-d068-4368-aff2-d46fa271acc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameH-Pette II (No Blade, Metal Canula) (1000 pieces)
Version Model Number3615
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM52536150 [Primary]

FDA Product Code

GJGPipette, Quantitative, Hematology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-22
Device Publish Date2017-05-26

Devices Manufactured by HELENA LABORATORIES CORPORATION

M5255527370 - SPIFE Nexus IFE-6 Antisera Kit2024-10-07
M5255527440 - SPIFE Nexus IFE-9/15 Antisera Kit2024-10-07
M52594190 - IFE IgD Antiserum2024-10-07
M52594200 - IFE IgE Antiserum2024-10-07
M52594220 - IFE Free Kappa Light Chain Antiserum2024-10-07
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

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