e-CHECK

GUDID 14987562460288

E-Check 4X4.5MLX3 Low/Normal/High

SYSMEX CORPORATION

Full blood count IVD, control
Primary Device ID14987562460288
NIH Device Record Keybc57689f-075d-4890-80bf-6a54fa77a736
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-CHECK
Version Model Number199-4004-1
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Dimensions

Total Volume4.5 Milliliter
Total Volume4.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS114987562460288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPKMIXTURE, HEMATOLOGY QUALITY CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-18
Device Publish Date2016-08-05

Devices Manufactured by SYSMEX CORPORATION

04987562503131 - XQ-320 XQ-Series Automated Hematology Analyzer2024-06-03 The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic
04987562020102 - CELLPACK2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
04987562020171 - CELLPACK2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
04987562022090 - STROMATOLYSER-3WP2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun
04987562022335 - STROMATOLYSER-FB2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l
04987562200269 - STROMATOLYSER-IM2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.
04987562201389 - STROMATOLYSER-4DS 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe
04987562201402 - STROMATOLYSER-4DL2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count*

Trademark Results [e-CHECK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
E-CHECK
E-CHECK
78116636 2978202 Dead/Cancelled
L-1 IDENTITY SOLUTIONS OPERATING COMPANY, INC.
2002-03-21
E-CHECK
E-CHECK
78058146 not registered Dead/Abandoned
United Computer & Telecommunication Inc.
2001-04-12
E-CHECK
E-CHECK
75700255 not registered Dead/Abandoned
MOURRE
1999-06-01
E-CHECK
E-CHECK
75093901 not registered Dead/Abandoned
Automatic Data Processing, Inc.
1996-04-25
E-CHECK
E-CHECK
74727141 not registered Dead/Abandoned
DANS, RONALD
1995-09-11

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