plt-CHECK

GUDID 14987562460615

plt-CHECK Level 2- 12X4.5ML

SYSMEX CORPORATION

Full blood count IVD, control
Primary Device ID14987562460615
NIH Device Record Key57d5c0bf-b87d-4e29-aef0-955d28cec805
Commercial Distribution StatusIn Commercial Distribution
Brand Nameplt-CHECK
Version Model Number200-4004-1
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
GS114987562460615 [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 Date2017-10-06

On-Brand Devices [plt-CHECK]

14987562460615plt-CHECK Level 2- 12X4.5ML
14987562460608plt-CHECK Level 1-12X4.5ML

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