FDA.report

Aerospray TB Slide Stainer/Cytocentrifuge

Primary DI
03661540303968
Brand
Aerospray TB Slide Stainer/Cytocentrifuge
Company
ELITECHGROUP INC.
Model
Model 7722
Device description
The Aerospray TB Slide Stainer/Cytocentrifuge (Model 7722) is a dual-purpose stainer intended for in vitro diagnostic use by medical professionals to stain microbiological specimens suspected of containing acid-fast organisms, a step in the standard laboratory practice of diagnosing disease in humans. The use of Aerospray TB reagents is required for successful use of this instrument. Adding the optional Cytopro rotor allows preparation of slides by cytocentrifugation before staining.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KPASlide Stainer, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661540303968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03661540303968036615403039683661540303968

GMDN Terms

TermDefinition
Microscope slide stainer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (800) 435 2725info@elitechgroup.com

Regulatory Flags

DUNS number
052423787
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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