COULTER S-CAL 179310

GUDID 15099590221881

COULTER S-CAL Calibrator Kit

Beckman Coulter, Inc.

Full blood count IVD, calibrator
Primary Device ID15099590221881
NIH Device Record Key68444ce8-0eea-4757-9019-359f6f522160
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER S-CAL
Version Model Number179310
Catalog Number179310
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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
GS115099590221881 [Primary]

FDA Product Code

KRYCalibrator For Platelet Counting

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

On-Brand Devices [COULTER S-CAL ]

15099590233761COULTER S-CAL Calibrator Kit
15099590233679COULTER S-CAL Calibrator Kit
15099590221881COULTER S-CAL Calibrator Kit

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