Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays 111010

GUDID 20816068020201

For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges.

ADVANCED INSTRUMENTS, INC.

Haematological cell analyser IVD, automated
Primary Device ID20816068020201
NIH Device Record Key112266c7-9dd2-4115-b843-b3600ff350d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Instruments GloCyte® Test Cartridge Kit - 8 Trays
Version Model Number111010
Catalog Number111010
Company DUNS125006353
Company NameADVANCED INSTRUMENTS, INC.
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816068020207 [Unit of Use]
GS120816068020201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKLCounter, Cell, Automated (Particle Counter)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-09-23

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