12-slide vented carousel for Aerospray®

GUDID 03661540300011

A 12-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.

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 Microscope slide stainer IVD
Primary Device ID03661540300011
NIH Device Record Keyee23c62c-89d2-43e4-96f1-04c47f985c2a
Commercial Distribution StatusIn Commercial Distribution
Brand Name12-slide vented carousel for Aerospray®
Version Model NumberAC-188
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540300011 [Primary]

FDA Product Code

KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-19

Devices Manufactured by ELITECHGROUP INC.

03661540300035 - Microsed-System® Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300042 - Mix-Rate® X20 Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300202 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300219 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300257 - Excyte® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300264 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300271 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy

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