Excyte® ESR Vacuum Tube, Carton EP-10605

GUDID 03661540300264

ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD
Primary Device ID03661540300264
NIH Device Record Key455b6663-8027-4bc7-ad65-28c40e16a384
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcyte® ESR Vacuum Tube, Carton
Version Model NumberEP-10605
Catalog NumberEP-10605
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count16
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540300264 [Unit of Use]
GS103661540300325 [Primary]

FDA Product Code

GKBDevice, Automated Sedimentation Rate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-10-01

On-Brand Devices [Excyte® ESR Vacuum Tube, Carton]

03661540300271ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantit
03661540300264ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantit

Trademark Results [Excyte]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCYTE
EXCYTE
97563455 not registered Live/Pending
Novoxa Biotech, Inc.
2022-08-24
EXCYTE
EXCYTE
78586565 3264296 Live/Registered
ELITECH GROUP, INC.
2005-03-14
EXCYTE
EXCYTE
75185813 2213683 Dead/Cancelled
BASF CATALYSTS LLC
1996-10-22

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