Aerospray Hematology Stat Slide Stainer/Cytocentrifuge

GUDID 03661540303937

The Aerospray Hematology Stat Slide Stainer/Cytocentrifuge (Model 7122) is intended for use by medical professionals to stain specimens that may include blood and other body fluids, as a step of standard laboratory practice in diagnosing disease in humans. Addition of the Cytopro rotor allows preparation of slides by cytocentrifugation before staining.

ELITECHGROUP INC.

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD
Primary Device ID03661540303937
NIH Device Record Key611cc175-fa5a-42c8-9e75-baef6fa9ccae
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerospray Hematology Stat Slide Stainer/Cytocentrifuge
Version Model NumberModel 7122
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]
GS103661540303937 [Primary]

FDA Product Code

KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated
KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-22
Device Publish Date2016-09-24

Devices Manufactured by ELITECHGROUP INC.

03661540302022 - Nanoduct® Electrode Cable Set Assembly2021-03-02 For use with Nanoduct Neonatal Sweat Analysis System to induce sweat for diagnosis of Cystic Fibrosis.
03661540300011 - 12-slide vented carousel for Aerospray®2021-03-01 A 12-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
03661540300028 - 30-slide vented carousel for Aerospray®2021-03-01 A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
03661540300196 - OSMOCOLL® HNL osmolality Controls, 6x1mL2021-03-01 Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer.
03661540301124 - Nanoduct® Calibration Standard Plate2021-03-01 For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic
03661540301179 - Cytopro® Rotor2021-03-01 The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass micros
03661540301483 - OPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mL2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.
03661540301490 - OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mL2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.

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