X-CAL Calibrator

GUDID 14987562460585

X-Cal Hematology Calibrator (4.6ML)

SYSMEX CORPORATION

Full blood count IVD, calibrator
Primary Device ID14987562460585
NIH Device Record Keyfa0a0816-7b09-48ce-8211-11a818ba6808
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-CAL Calibrator
Version Model Number110-4009-0
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 Volume4.6 Milliliter
Total Volume4.6 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
GS114987562460585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRXCALIBRATOR FOR CELL INDICES

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 Date2016-08-04

On-Brand Devices [X-CAL Calibrator]

14987562460592X-Cal FSR Kit (5X4.6ML)
14987562460585X-Cal Hematology Calibrator (4.6ML)

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